10q10k10q10k.net

What changed in DBV Technologies S.A.'s 10-K — 2023 vs 2024

vs

Paragraph-level year-over-year comparison of DBV Technologies S.A.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+500 added−493 removedSource: 10-K (2025-04-11) vs 10-K (2024-03-07)

Top changes in DBV Technologies S.A.'s 2024 10-K

500 paragraphs added · 493 removed · 355 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

146 edited+85 added−58 removed317 unchanged
Biggest changeThe data collection phase of the trial is complete, and the data analysis phase is ongoing. b. ‘EQUAL in adults,’ a second Phase 1 trial with adult healthy volunteers to compare the allergen uptake of the original patch (which we call cVP) and mVP. 5 In March 2021, we commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches.
Biggest changeIn March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches to confirm consistency of efficacy data between the existing and modified patches.
Viaskin Milk Our second product candidate, Viaskin Milk, is in development for the treatment of cow’s milk protein allergy, (IgE-mediated) or CMPA, in children two to 17 years of age, and received fast track designation from the FDA in 17 September 2016.
Viaskin Milk Our second product candidate, Viaskin Milk, is in development for the treatment of cow’s milk protein allergy, (IgE-mediated) or CMPA, in children two to 17 years of age, and received fast track designation from the FDA in September 2016.
Accordingly, if the remaining patent term has fourteen (14) or more years after the FDA approval date, the patent would not be eligible for any patent extension.
Accordingly, if the remaining patent term has fourteen (14) or more years after the FDA approval date, the patent would not be eligible for any patent term extension.
Biosimilarity, which requires that the biological product be highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there be no clinically meaningful differences between the product and the reference product in terms of safety, purity, and potency, which can be shown through analytical studies, animal studies, and a clinical trial or trials.
Biosimilarity, which requires that the biological product be highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, which can be shown through analytical studies, animal studies, and a clinical trial or trials.
Fast track designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process. Breakthrough Designation The Food and Drug Administration Safety and Innovation Act, or FDASIA, amended the FDCA to require the FDA to expedite the development and review of a breakthrough therapy.
Fast track designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process. Breakthrough Therapy Designation The Food and Drug Administration Safety and Innovation Act, or FDASIA, amended the FDCA to require the FDA to expedite the development and review of a breakthrough therapy.
This assessment is then submitted to the competent authorities of all the concerned EU Member States in which the trial is to be conducted for their review. Part II is assessed separately by the competent authorities and Ethics Committees in each concerned EU Member State.
This assessment is then submitted to the competent authorities of all concerned EU Member States in which the trial is to be conducted for their review. Part II is assessed separately by the competent authorities and Ethics Committees in each concerned EU Member State.
Specifically, under regulations issued by the FDA, a combination product may be: • a product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity; 27 • two or more separate products packaged together in a single package or as a unit and comprised of drug and device products; • a drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device or biological where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or • any investigational drug, device, or biological packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
Specifically, under regulations issued by the FDA, a combination product may be: • a product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity; • two or more separate products packaged together in a single package or as a unit and comprised of drug and device products; • a drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device or biological where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or • any investigational drug, device, or biological packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
Similar to the federal Anti- Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; • the federal Physician Payments Sunshine Act, enacted as part of the ACA, which requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals and information regarding certain ownership and investment interests held by physicians or their immediate family members; • federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which imposes certain requirements on covered entities and their business associates, and their covered subcontractors, relating to the privacy, security and transmission of individually identifiable health information; and • state, local and foreign law equivalents of each of the above federal laws, such as state anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements; state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require licensure or registration by pharmaceutical sales representatives; state laws that require disclosure of information related to drug pricing; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA, thus complicating compliance efforts.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; • the federal Physician Payments Sunshine Act, enacted as part of the ACA, which requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals and information regarding certain ownership and investment interests held by physicians or their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which imposes certain requirements on covered entities and their business associates, and their covered subcontractors, relating to the privacy, security and transmission of individually identifiable health information; and • state, local and foreign law equivalents of each of the above federal laws, such as state anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements; state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require licensure or registration by pharmaceutical sales representatives; state laws that require disclosure of information related to drug pricing; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA, thus complicating compliance efforts.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant administrative, civil, and/or criminal penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, or comparable foreign programs, integrity obligations, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or 41 restructuring of our operations.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant administrative, civil, and/or criminal penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, or comparable foreign programs, integrity obligations, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations.
Differentiating competitive factors in the pharmaceutical industry include product efficacy and safety; quality and breadth of an 22 organization’s technology; skill of an organization’s employees and its ability to recruit and retain key employees; timing and scope of regulatory approvals; government reimbursement rates for, and the average selling price of, products; the availability of raw materials and qualified manufacturing capacity; manufacturing and distribution costs; intellectual property and patent rights and their protection; and sales and marketing capabilities.
Differentiating competitive factors in the pharmaceutical industry include product efficacy and safety; quality and breadth of an organization’s technology; skill of an organization’s employees and its ability to recruit and retain key employees; timing and scope of regulatory approvals; government reimbursement rates for, and the average selling price of, products; the availability of raw materials and qualified manufacturing capacity; manufacturing and distribution costs; intellectual property and patent rights and their protection; and sales and marketing capabilities.
Epicutaneous, also known as on the skin, immunotherapy, or EPIT, exposes tolerance-promoting immune cells in the skin to an adhesive dermal patch containing a small (micrograms) dose of antigen, such as food protein. This 2 technology platform, which we call Viaskin, is an innovative approach to potentially treating immunological disorders, with a primary focus on food allergy.
Epicutaneous, also known as on the skin, immunotherapy, or EPIT, exposes tolerance-promoting immune cells in the skin to an adhesive dermal patch containing a small (micrograms) dose of antigen, such as food protein. This technology platform, which we call Viaskin, is an innovative approach to potentially treating immunological disorders, with a primary focus on food allergy.
To support the application, the MA holder must provide the EMA or the competent authority with a consolidated version of the eCTD (Common Technical Document) providing up-to-date data concerning the quality, safety and efficacy of the product, including all variations introduced 33 since the MA was granted, at least nine months before the MA ceases to be valid.
To support the application, the MA holder must provide the EMA or the competent authority with a consolidated version of the eCTD (Common Technical Document) providing up-to-date data concerning the quality, safety and efficacy of the product, including all variations introduced since the MA was granted, at least nine months before the MA ceases to be valid.
PEPITES was a global, randomized 2:1, double-blind, placebo-controlled Phase 3 trial, in which 356 pediatric peanut-allergic patients were treated with Viaskin Peanut 250 µg or placebo for 12 months. A new patch was applied each day, and after 2 weeks, each patch was worn for 24 hours, plus-or-minus 4 hours.
PEPITES was a global, randomized 2:1, double-blind, placebo-controlled Phase 3 trial, in which 356 pediatric peanut-allergic patients were treated with Viaskin Peanut 250 μg or placebo for 12 months. A new patch was applied each day, and after two weeks, each patch was worn for 24 hours, plus-or-minus 4 hours.
We were incorporated as a société par actions simplifiée (S.A.S.) under the laws of the French Republic on March 29, 2002 for a period of 99 years and subsequently converted on March 13, 2003 into a société anonyme . We are registered at the Nanterre Commerce 42 and Companies Register under the number 441 772 522.
We were incorporated as a société par actions simplifiée (S.A.S.) under the laws of the French Republic on March 29, 2002 for a period of 99 years and subsequently converted on March 13, 2003 into a société anonyme . We are registered at the Nanterre Commerce and Companies Register under the number 441 772 522.
The Joint Select Committee on Deficit Reduction was tasked with recommending to Congress proposals in spending reductions. Because they did not achieve a targeted deficit reduction of at least 38 $1.2 trillion for fiscal years 2012 through 2021, it triggered the legislation’s automatic reduction to several government programs.
The Joint Select Committee on Deficit Reduction was tasked with recommending to Congress proposals in spending reductions. Because they did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, it triggered the legislation’s automatic reduction to several government programs.
The CTR also establishes a single set of documents to be prepared and submitted for the application including, among other things, a copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation, as well as simplified reporting procedures for clinical trial sponsors.
The CTR also establishes a single set of documents to be prepared and submitted for the application including, among other things, a copy of the trial protocol and an Investigational Medicinal Product Dossier (“IMPD”)containing information about the manufacture and quality of the medicinal product under investigation, as well as simplified reporting procedures for clinical trial sponsors.
Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety and assess efficacy. Each protocol, and any subsequent amendments to such protocol, must be submitted to the FDA as part of the IND.
Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection (inclusion and exclusion criteria), and the parameters to be used to monitor subject safety and assess efficacy. Each protocol, and any subsequent amendments to such protocol, must be submitted to the FDA as part of the IND.
Sales of our products will depend, in part, on the extent to 37 which our products, once approved, will be covered and reimbursed by third-party payors, such as government health programs, commercial insurance and managed healthcare organizations. These third-party payors are increasingly reducing reimbursements for medical products and services.
Sales of our products will depend, in part, on the extent to which our products, once approved, will be covered and reimbursed by third-party payors, such as government health programs, commercial insurance and managed healthcare organizations. These third-party payors are increasingly reducing reimbursements for medical products and services.
Other Regulatory Matters UK Regulations The United Kingdom’s, or UK, withdrawal from the EU on January 31, 2020, commonly referred to as Brexit, has changed the regulatory relationship between the UK and the EU. The Medicines and Healthcare products Regulatory Agency, or MHRA, is now the UK’s standalone regulator for medicinal products and medical 36 devices.
Other Regulatory Matters UK Regulations The United Kingdom’s, or UK, withdrawal from the EU on January 31, 2020, commonly referred to as Brexit, has changed the regulatory relationship between the UK and the EU. The Medicines and Healthcare products Regulatory Agency, or MHRA, is now the UK’s standalone regulator for medicinal products and medical devices.
The key elements of the Viaskin patch mechanism of action, which are illustrated below, are the following: • Containing a dry layer of allergen in its center, the patch is positioned on intact skin, without prior preparation. • The condensation chamber formed between the skin and the center of the patch creates hyperhydration of the skin and an accumulation of water. • The accumulation of water solubilizes the allergen.
The key elements of the Viaskin patch mechanism of action, illustrated below, are the following: • Containing a dry layer of allergen in its center, the patch is positioned on intact skin, without prior preparation. • The condensation chamber formed between the skin and the center of the patch creates hyperhydration of the skin and an accumulation of water. • The accumulation of water solubilizes the allergen.
Langerhans cells in the epidermis capturing peanut allergen (depicted in green) within the stratum corneum (the outermost layer of the skin) following solubilization of allergen and permeation into the skin after Viaskin patch application. 3 Our Product Candidates Our product development strategy is based on leveraging Viaskin’s clinical potential.
Langerhans cells in the epidermis capturing peanut allergen (depicted in green) within the stratum corneum (the outermost layer of the skin) following solubilization of allergen and permeation into the skin after Viaskin patch application. Our Product Candidates Our product development strategy is based on leveraging Viaskin’s clinical potential.
There was 13 agreement with the FDA to conduct a supplemental safety study (COMFORT Toddlers) using the original square (cVP) Viaskin ™ Peanut patch to augment the safety data collected from EPITOPE and have close to 600 total subjects on active treatment in the controlled safety database.
There was agreement with the FDA to conduct a supplemental safety study (COMFORT Toddlers) using the original square (cVP) Viaskin Peanut patch to augment the safety data collected from EPITOPE and have close to 600 total subjects on active treatment in the controlled safety database.
Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA Member States may result in fines up to 20 million Euros or 4% of a company’s global annual revenues for the preceding financial year, whichever is higher.
Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA Member States may result in fines up to €20 million or 4% of a company’s global annual revenues for the preceding financial year, whichever is higher.
Generally, before a new drug or biologic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. 23 U.S.
Generally, before a new drug or biologic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. U.S.
We believe that with improved knowledge about the evolution of immunological biomarkers and epigenetic modulation, we may be able to determine the level of patient response earlier during treatment, ensure follow-up and measure tolerance 18 maintained once treatment is completed.
We believe that with improved knowledge about the evolution of immunological biomarkers and epigenetic modulation, we may be able to determine the level of patient response earlier during treatment, ensure follow-up and measure tolerance maintained once treatment is completed.
An additional post-hoc analysis showed that 53.1% of subjects treated with Viaskin Peanut increased their baseline ED from 100 mg or less to 300 mg or 8 more, compared to 19% in the placebo group.
An additional post-hoc analysis showed that 53.1% of subjects treated with Viaskin Peanut increased their baseline ED from 100 mg or less to 300 mg or more, compared to 19% in the placebo group.
Low discontinuations due to adverse events were observed, with two children discontinuing the trial due to treatment- related TEAEs during PEOPLE. 10 Exploratory analyses suggest Viaskin Peanut may offer sustained effect even after a period without treatment.
Low discontinuations due to adverse events were observed, with two children discontinuing the trial due to treatment-related TEAEs during PEOPLE. Exploratory analyses suggest Viaskin Peanut may offer sustained effect even after a period without treatment.
Based on our trials and research, we believe that EPIT has the potential to provide all of the intended benefits of a disease-modifying treatment in allergy, while avoiding severe or life-threatening allergic reactions.
Based on our trials and research, we believe that EPIT has the potential to provide the intended benefits of a disease-modifying treatment in allergy, while avoiding severe or life-threatening allergic reactions.
Although general requirements for advertising and promotion of medicinal products are established under EU legislation, the details are governed by 35 regulations in individual EU Member States and can differ from one country to another.
Although general requirements for advertising and promotion of medicinal products are established under EU legislation, the details are governed by regulations in individual EU Member States and can differ from one country to another.
The PDCO can grant a deferral of the obligation to implement some or all of the measures provided in the PIP until 34 there are sufficient data to demonstrate the efficacy and safety of the product in adults.
The PDCO can grant a deferral of the obligation to implement some or all of the measures provided in the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults.
In the future, if a Viaskin patch receives FDA approval, we expect to apply for a patent term extension on the patent that we believe will provide the best exclusivity position if extended.
In the future, if a Viaskin patch receives FDA approval, we expect to apply for a patent term extension on the patent that we believe will provide the best exclusivity position for that product if extended.
The MILES (Milk Efficacy and Safety) clinical trial was designed to determine a safe and effective dose in two age groups: children ages two to 11 and adolescents ages 12 to 17.
The MILES (Milk Efficacy and Safety) clinical trial was designed to determine a safe and effective dose in two age groups: children ages 2 to 11 and adolescents ages 12 to 17.
As a condition of approval, the FDA may require that a sponsor of a 28 drug or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials.
As a condition of approval, the FDA may require that a sponsor of a drug or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials.
We are advancing this unique technology to treat children suffering from food allergies for whom safety is paramount since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients.
We are advancing this unique technology to treat children suffering from food allergies for whom safety is paramount since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, , non-invasive immunotherapy to patients.
Viaskin Peanut demonstrated a statistically significant treatment effect (p 12 † Responder definition = If eliciting dose (ED) ≤10 mg at baseline, a subject is deemed a responder if ED ≥300 mg at M12.
Viaskin Peanut demonstrated a statistically significant treatment effect (p † Responder definition = If eliciting dose (ED) ≤10 mg at baseline, a subject is deemed a responder if ED ≥300 mg at M12.
The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose, or ED, which may decrease the chance of reacting to an accidental peanut exposure. Results of the PEOPLE trial for participants receiving 3 years of active treatment were published in the Journal of Allergy and Clinical Immunology in October 2020.
The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose, or ED, which may decrease the chance of reacting to an accidental peanut exposure. Results of the PEOPLE trial for participants receiving three years of active treatment were published in the Journal of Allergy and Clinical Immunology in October 2020.
If any such changes were to be imposed, they could adversely affect the operation of our business. European Union Drug Development In the European Union, or the EU, product candidates may also be subject to extensive regulatory requirements. Approval from the competent authorities of EU Member States must be obtained before commencing clinical trials.
If any such changes were to be imposed, they could adversely affect the operation of our business. European Union Drug Development In the European Union, or the EU, product candidates are also subject to extensive regulatory requirements. Approval from the competent authorities of EU Member States must be obtained before commencing clinical trials.
A harmonized procedure for the assessment of applications for clinical trials has been introduced and is divided into two parts. Part I assessment is led by the competent authorities of a reporting EU Member State selected by the trial sponsor and relates to clinical trial aspects that are considered to be scientifically harmonized across EU Member States.
A harmonized procedure for the assessment of applications for clinical trials has been introduced and is divided into two parts. Part I assessment is led by the competent authorities of a reference EU Member State selected by the trial sponsor and relates to clinical trial aspects that are considered to be scientifically harmonized across EU Member States.
In the future, we may apply for extension of patent term for our currently owned or licensed patents to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.
In the future, we may apply for extension of patent term for our currently owned or licensed patents to add patent term beyond its then-current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.
Results of REALISE Trial Results from the 6-month blinded portion of this trial were comparable with outcomes from previous trials of Viaskin Peanut 250 µg. The most commonly reported adverse events were local application site reactions, which were mostly mild and moderate in nature.
Results of REALISE Trial Results from the six-month blinded portion of this trial were comparable with outcomes from previous trials of Viaskin Peanut 250 μg. The most commonly reported adverse events were local application site reactions, which were mostly mild and moderate in nature.
Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act; • federal civil and criminal false claims laws, including the federal civil False Claims Act, which impose penalties and provide for civil whistleblower or qui tam actions, and civil monetary penalty laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for 40 payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money to the federal government, including for example, providing inaccurate billing or coding information to customers or promoting a product off-label; • HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, knowingly and willfully falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters, knowingly and willfully embezzling or stealing from a healthcare benefit program, or willfully obstructing a criminal investigation of a healthcare offense.
Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act; • federal civil and criminal false claims laws, including the federal civil False Claims Act, which impose penalties and provide for civil whistleblower or qui tam actions, and civil monetary penalty laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money to the federal government, including for example, providing inaccurate billing or coding information to customers or promoting a product off-label; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, knowingly and willfully falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters, knowingly and willfully embezzling or stealing from a healthcare benefit program, or willfully obstructing a criminal investigation of a healthcare offense.
Each party remains responsible for its own costs and expenses related to its respective wind-down activities. Any and all licenses and sublicenses, granted by either party to the other party under the Collaboration Agreement, including, without limitation, any licenses to intellectual property, were revoked and terminated.
Each party remained responsible for its own costs and expenses related to its respective wind-down activities. Any and all licenses and sublicenses, granted by either party to the other party under the Collaboration Agreement, including, without limitation, any licenses to intellectual property, were revoked and terminated.
Data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product, after which a generic or biosimilar MAA can be submitted, and the innovator’s data may be referenced.
Data exclusivity, if granted, prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product, after which a generic or biosimilar MAA can be submitted, and the innovator’s data may be referenced.
The frequency of treatment related TEAEs also decreased in year 2 relative to year 1. There were no treatment related serious TEAEs reported during the 2 nd year of treatment (versus 1% in EPITOPE). As observed during the first year of treatment with Viaskin Peanut, no TEAEs led to permanent study treatment discontinuation.
The frequency of treatment related TEAEs also decreased in Year 2 relative to Year 1. There were no treatment related serious TEAEs reported during the second year of treatment (versus 1% in EPITOPE). As observed during the first year of treatment with Viaskin Peanut, no TEAEs led to permanent study treatment discontinuation.
“First 21 licensure” typically means the initial date the particular product at issue was licensed in the United States.
“First licensure” typically means the initial date the particular product at issue was licensed in the United States.
Accordingly, we cannot be sure that submission of an IND will 24 result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that could cause the trial to be suspended or terminated.
Accordingly, we cannot be sure that submission of an original IND submission will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that could cause the trial to be suspended or terminated.
These patents and applications generally fall into five broad categories: • two U.S. patents, which we own, relating to the Viaskin electrostatic patch and its use, which expired in 2022; 20 • patents and patent applications which we own relating to our electrospray method of manufacturing the Viaskin electrostatic patch, which may expire as early as 2029; • patents and patent applications we co-own with Assistance-Publique-Hôpitaux de Paris, or AP-HP, and the Université Paris Cité (formerly Université de Paris-Descartes, prior to merger and name change) relating to the treatment of peanut, milk, egg, and other allergies using our Viaskin patch technology, which may expire as early as 2028; • design patents and patent applications, which we own relating to various components of the Viaskin patch, which may expire as early as 2038; and • a variety of other patent applications that we own or co-own relating, for example, to prophylactic uses of the Viaskin patch technology and to treatment of other indications using the Viaskin patch technology.
These patents and applications generally fall into five broad categories: • two U.S. patents, which we co-own with with Assistance Publique-Hôpitaux de Paris, or AP-HP, and Université Paris Cité (formerly Université de Paris-Descartes,and prior to that, Université de Paris, prior to merger and name change), relating to the Viaskin electrostatic patch and its use, which expired in 2022; • patents and patent applications which we own relating to our electrospray method of manufacturing the Viaskin electrostatic patch, which may expire as early as 2029; • patents and patent applications we co-own with AP-HP, and the Université Paris Cité relating to the treatment of peanut, milk, egg, and other allergies using our Viaskin patch technology, which may expire as early as 2028; • design patents and patent applications, which we own relating to various designs of components of the Viaskin patch, which may expire as early as 2032; and • a variety of other patent applications that we own or co-own relating, for example, to prophylactic uses of the Viaskin patch technology and to treatment of other indications using the Viaskin patch technology, and to other technologies.
It is unclear how such challenges and the healthcare reform measures of the Biden administration will impact the ACA. In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 among other things, created measures for spending reductions by Congress.
It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the ACA. In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 among other things, created measures for spending reductions by Congress.
Four (1.6%) subjects in the Viaskin Peanut arm experienced an anaphylactic reaction determined to be related to, or possibly related to, treatment. Among these anaphylactic reactions, 3 resolved with a single dose of epinephrine and 1 resolved without epinephrine. All anaphylactic reactions were mild to moderate in severity and were characterized mainly by skin and respiratory symptoms.
Four (1.6%) subjects in the Viaskin Peanut arm experienced an anaphylactic reaction determined to be related to, or possibly related to, treatment. Among these anaphylactic reactions, three resolved with a single dose of epinephrine and one resolved without epinephrine. All anaphylactic reactions were mild to moderate in severity and were characterized mainly by skin and respiratory symptoms.
In October 2023, the MHRA announced a new Notification Scheme for clinical trials which enables a more streamlined and risk-proportionate approach to initial clinical trial applications for Phase 4 and low-risk Phase 3 clinical trial applications. Marketing authorizations in the UK are governed by the Human Medicines Regulations (SI 2012/1916), as amended.
In October 2023, the MHRA announced a new Notification Scheme for clinical trials which enables a more streamlined and risk-proportionate approach to initial clinical trial applications for Phase 4 and low-risk Phase 3 clinical trial applications. Marketing authorizations in the United Kingdom are governed by the Human Medicines Regulations (SI 2012/1916), as amended.
These studies are evaluating forms of allergen desensitization treatments such as oral, or OIT; sublingual, or SLIT; subcutaneous, or SCIT; oral mucosal, or OMIT; and cutaneuos or intranasal immunotherapy, synthetic, denatured allergens, small molecule inhibitors, or combinations of medicines or methods. Studies combining methods of allergen immunotherapy, such as OIT, with monoclonal antibodies also are being conducted currently.
These studies are evaluating forms of allergen desensitization treatments such as oral, or OIT; sublingual, or SLIT; subcutaneous, or SCIT; oral mucosal, or OMIT; cutaneous and intranasal, or INT immunotherapy, synthetic, denatured allergens, small molecule inhibitors, or combinations of medicines or methods. Studies combining methods of allergen immunotherapy, such as OIT, with monoclonal antibodies also are being conducted currently.
Once a BLA has been accepted for filing, which occurs, if at all, sixty days after the BLA’s submission, the FDA’s goal is to review such BLA within ten months of the filing date for standard review or six months of the filing date for priority review (if granted by the FDA), if the application is for a product intended for a serious or life-threatening condition and the product, if approved, would provide a significant improvement in safety or effectiveness.
Once a BLA has been accepted for filing, which occurs, if at all, sixty days after the BLA’s submission, the FDA’s goal is to review such BLA within ten months of the filing date for standard review or six months of the filing date for priority review (if granted by the FDA), if the application is for a product intended for a serious or life-threatening condition and the product, if approved, would provide a significant improvement in safety or effectiveness compared to other currently approved products for the condition.
Regarding safety and tolerability findings, no new safety signals were observed, and findings were generally similar to what was reported during the first year of treatment with Viaskin Peanut in EPITOPE. Local application site reactions continued to be the most reported adverse event, with frequency decreasing during the 2 nd year of treatment.
Regarding safety and tolerability findings, no new safety signals were observed, and findings were generally similar to what was reported during the first year of treatment with Viaskin Peanut in EPITOPE. Local application site reactions continued to be the most reported adverse event, with frequency decreasing during the second year of treatment.
Absent early termination, the assignment, development and co-ownership agreement will automatically terminate upon the expiration of the last shared patent. In the event the agreement is terminated, we would no longer have the exclusive right to commercial use of the shared patents, though we would retain our shared ownership rights.
Absent early termination, the assignment, development and co-ownership agreement will automatically terminate upon the expiration cancellation, or abandonment of the last shared patent. In the event the agreement is terminated, we would no longer have the exclusive right to commercial use of the shared patents, though we would retain our shared ownership rights.
Similarly, an IRB can suspend or 25 terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product has been associated with unexpected serious harm to subjects or patients.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements and/or protocol or if the product has been associated with unexpected serious harm to subjects or patients.
Upon the grant of a marketing authorization with orphan status, the medicinal product will benefit from up to 10 years of market exclusivity from similar products in the approved orphan indication. The start of this market exclusivity period will be set from the date of first approval of the product in Great Britain.
Upon the grant of a marketing authorization with orphan status, the medicinal product will benefit from up to 10 years of market exclusivity from similar products in the approved orphan indication. The start of this market exclusivity period will be set from the date of first approval of the product in the UK.
A proprietary form of OIT, Palforzia ® , is approved in the US and the European Union for the treatment of peanut allergy in children aged 4–17 years.
A proprietary form of OIT, Palforzia®, is approved in the US and the European Union for the treatment of peanut allergy in children aged 1–17 years.
A difference in the CRD was observed between Viaskin Peanut and placebo (nominal p-value Exploratory analyses showed that changes in peanut-specific biomarkers, including immunoglobulin E(IgE), and immunoglobulin G4(IgG4), support the immunomodulatory effect of Viaskin Peanut.
A difference in the CRD was observed between Viaskin Peanut and placebo (nominal p-value CRD after 12 months Exploratory analyses showed that changes in peanut-specific biomarkers, including immunoglobulin E (IgE), and immunoglobulin G4(IgG4), support the immunomodulatory effect of Viaskin Peanut.
This compares to 67% of subjects after one year of therapy. 81.3% of Viaskin Peanut subjects reached an eliciting dose (ED) of ≥1000 mg (equivalent to 14 approximately 3 peanuts; central chart), relative to 64% after 1-year of treatment observed in EPITOPE.
This compares to 67% of subjects after one year of therapy. 81.3% of Viaskin Peanut subjects reached an eliciting dose (ED) of ≥1000 mg (equivalent to approximately three peanuts; central chart), relative to 64% after one-year of treatment observed in EPITOPE.
The FDA agreed with our position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1,000 of one peanut) remains unchanged and performs in the same way it has performed previously.
The FDA agreed with the Company’s position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously.
Overall, 21 subjects (8.6%) in the Viaskin Peanut arm and 3 subjects (2.5%) in the placebo arm experienced a serious adverse event (SAE). Only 1 of the SAEs (0.4%), which was mild periorbital edema (swelling around the eye) in the Viaskin Peanut arm, was deemed related to treatment.
Overall, 21 subjects (8.6%) in the Viaskin Peanut arm and three subjects (2.5%) in the placebo arm experienced a serious adverse event (SAE). Only one of the SAEs (0.4%), which was mild periorbital edema (swelling around the eye) in the Viaskin Peanut arm, was deemed related to treatment.
Subjects randomized to active treatment in EPITOPE could receive an additional 2-years of treatment in the OLE and subjects randomized to placebo in EPITOPE cross-over to receive 3 years of active treatment with annual double-blind placebo-controlled food challenges (DBPCFC) and safety assessments. 266 eligible EPITOPE participants enrolled in EPOPEX; 244 underwent the Month-24 DBPCFC (n=166 subjects treated with Viaskin Peanut 250 µg for 24 months); 78 subjects originally randomized to the placebo arm of EPITOPE who crossed-over and received active treatment with Viaskin Peanut for 1 year in the OLE.
Subjects randomized to active treatment in EPITOPE could receive an additional two-years of treatment in the OLE and subjects randomized to placebo in EPITOPE cross-over to receive three years of active treatment with annual double-blind placebo-controlled food challenges (DBPCFC) and safety assessments. 266 eligible EPITOPE participants enrolled in EPOPEX. 244 underwent the month-24 DBPCFC (n=166 subjects treated with Viaskin Peanut 250 μg for 24 months); 78 subjects originally randomized to the placebo arm of EPITOPE who crossed-over and received active treatment with Viaskin Peanut for one year in the OLE.
On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.
For example, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.
On August 2, 2021, we announced we had received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process.
On August 2, 2021, we announced we had received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA identified one major objection remained at Day 180.
There is one treatment for peanut allergy approved by the FDA and the European Commission: Palforzia, a formulation of peanut flour developed by Aimmune Therapeutics, Inc., or Aimmune. Nestlé S.A. acquired Aimmune in October 2020 and divested the Palforzia business to Stallergenes Greer in September 2023.
There is one treatment for peanut allergy in children 1 to 17 years of age approved by the FDA and the European Commission: Palforzia, a formulation of peanut flour developed by Aimmune Therapeutics, Inc., or Aimmune. Nestlé S.A. acquired Aimmune in October 2020 and divested the Palforzia business to Stallergenes Greer in September 2023.
We expect that additional federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain development projects and reduce our profitability.
We expect that additional federal healthcare reform measures will be adopted in the future, particularly given the recent change in administration, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain development projects and reduce our profitability.
The FDA may refer applications for novel drug product candidates or drug product candidates which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to 26 whether the application should be approved and under what conditions.
The FDA may refer applications for novel drug product candidates or drug product candidates which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and usually a vote by the members as to whether the application should be approved and under what conditions.
The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.
In addition, the FDA indicated that supplementary clinical data would need to be generated to support the modified patch. Finally, the FDA requested additional Chemistry, Manufacturing and Controls (“CMC”) data. The FDA did not raise any safety concerns related to Viaskin Peanut.
We have also entered into a Commercial Supply Agreement, dated January 13, 2020, as amended (the “Commercial Supply Agreement”), with FAREVA setting forth the terms and conditions for the manufacture and supply of commercial batches of Viaskin Peanut by FAREVA.
We have also entered into a Commercial Supply Agreement, dated January 13, 2020, as amended (the “Commercial Supply Agreement”), with FAREVA setting forth the terms and conditions for the manufacture and supply of commercial batches of Viaskin Peanut by FAREVA. We previously agreed with FAREVA to delay implementation of the Commercial Supply Agreement.
While march-in rights have not previously been exercised, it isuncertain if that will continue under the new framework.
While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.
As such, in December 2021, we announced our plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. We consider this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system.
As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considered this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the mVP.
Additionally, in the United States, there have been several recent Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
Additionally, in the United States, there have been several recent Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. At the federal level, the IRA, among other things, (i) directs the U.S.
United States Regulatory History Viaskin Peanut obtained fast track designation and breakthrough therapy designation in children from the FDA, which are regulatory designations intended to expedite or facilitate the process of reviewing new drugs and 4 biological products that are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.
Viaskin Peanut Our lead product candidate, Viaskin Peanut obtained fast track designation and breakthrough therapy designation in children from the FDA, which are regulatory designations intended to expedite or facilitate the process of reviewing new drugs and biological products that are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.
PEPITES ( Pea nut EPIT Eff icacy and Saf ety Study) In December 2015, we initiated a pivotal Phase 3 trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 µg in children four to 11 years of age suffering from peanut allergy.
PEPITES (Peanut EPIT Efficacy and Safety Study) In December 2015, we initiated a pivotal Phase 3 trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 μg in children four to 11 years of age suffering from peanut allergy.
One subject experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without treatment. Treatment compliance remained high throughout the trial at a mean of 98% over three years of treatment.
No treatment related serious adverse events were reported. One subject experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without treatment. Treatment compliance remained high throughout the trial at a mean of 98% over three years of treatment.
In addition, our ownership stake in certain jointly made improvements covered by the shared patents would survive termination of the agreement. The longest-lived patent rights under the agreement are currently expected to expire in 2031, absent patent term extension.
In addition, our ownership stake in certain jointly made improvements covered by, or depending on, at least one of the shared patents would survive termination of the agreement. The longest-lived patent rights under the agreement are currently expected to expire in 2031, absent patent term extension.
The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of data or full or partial waivers. 29 Post-Marketing Requirements Following approval of a new product, a manufacturer and the approved product are subject to continuing regulation by the FDA, including, among other things, monitoring and recordkeeping activities, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved labeling, also known as off-label use, limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.
Post-Marketing Requirements Following approval of a new product, a manufacturer and the approved product are subject to continuing regulation by the FDA, including, among other things, monitoring and recordkeeping activities, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved labeling, also known as off-label use, limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.
The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries.
The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to the IRB’s, health authorities and public registries (such as clinicaltrials.gov).
With regard to biopharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare Part D program. However, there have been executive, judicial and Congressional challenges to certain aspects of the ACA. For example, on June 17, 2021 the U.S.
With regard to biopharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare Part D program. However, there have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA.
This program is independent from the Viaskin Peanut Program in 4–7-year-olds and uses the cVP (original patch). 11 The Viaskin Peanut program for toddlers comprises three Phase 3 clinical trials, with the intent for the trials to support a future BLA submission in this age group: • EPITOPE (EPIT in Toddlers with Peanut Allergy) , a randomized, two-part, pivotal Phase 3 clinical trial assessing the safety and efficacy of Viaskin Peanut for the treatment of peanut-allergic toddlers one to three years of age. • COMFORT Toddlers ( Characterization of the Optimal Management of Food allergy Relief and Treatment), a supplemental safety study to bring the (total) number of subjects on active therapy close to 600 in total when combined with EPITOPE. • EPOPEX ( Phase 3 Open-Label Extension to the EPITOPE Trial), a follow-up of the EPITOPE study to evaluate the long-term efficacy and safety of Viaskin Peanut in very young children, In August 2017, we initiated Part A of the EPITOPE (EPIT in Toddlers with Peanut Allergy) trial of Viaskin Peanut.
The Viaskin Peanut program for toddlers comprises three Phase 3 clinical trials, with the intent for the trials to support a future BLA submission in this age group: • EPITOPE (EPIT in Toddlers with Peanut Allergy), a randomized, two-part, pivotal Phase 3 clinical trial assessing the safety and efficacy of Viaskin Peanut for the treatment of peanut-allergic toddlers one to three years of age; • COMFORT Toddlers (Characterization of the Optimal Management of Food allergy Relief and Treatment), a supplemental safety study to bring the (total) number of subjects on active therapy close to 600 in total when combined with EPITOPE; • EPOPEX (Phase 3 Open-Label Extension to the EPITOPE Trial), a follow-up of the EPITOPE study to evaluate the long-term efficacy and safety of Viaskin Peanut in very young children.

… 209 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

136 edited+30 added−54 removed525 unchanged
Biggest changeIn this case securities cannot be sold in such an offering at a price that is more than a 15% discount to (i) the last closing price of the Company’s shares on the regulated market Euronext Paris prior to the date on which the issue price is set, (ii) the volume-weighted average price of the share of the Company on the regulated market of Euronext Paris over a period determined by the Board of Directors of between one to five consecutive trading days chosen from the last thirty trading days prior to the date on which the issue price is set. 46 Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises such as the COVID-19 pandemic, political crises, geopolitical events, such as the crisis in Ukraine and the Israel-Hamas war, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.
Biggest changeIn this case securities cannot be sold in such an offering at a price that is more than a 15% discount to (i) the last closing price of the Company’s shares on the regulated market Euronext Paris prior to the date on which the issue price is set, (ii) the volume-weighted average price of the share of the Company on the regulated market of Euronext Paris over a period determined by the Board of Directors of between one to five consecutive trading days chosen from the last thirty trading days prior to the date on which the issue price is set.
The full extent the impact of any future public health crises on our clinical development and other operations and financial performance depends on continuing developments that are uncertain and unpredictable, including the timing of any future vaccine development and rollouts and herd immunity, virus mutations and variants, and any new information that may emerge concerning future virus, vaccines, and containment, all of which may vary across regions.
The full extent of the impact of any future public health crises on our clinical development and other operations and financial performance depends on continuing developments that are uncertain and unpredictable, including the timing of any future vaccine development and rollouts and herd immunity, virus mutations and variants, and any new information that may emerge concerning future virus, vaccines, and containment, all of which may vary across regions.
However, there is no guarantee that a product will be considered by the European Union’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
There is, however, no guarantee that a product will be considered by the European Union’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. • The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members in the applicable manufacturer, and disclosure of such information will be made by CMS on a publicly available website. 71 • Analogous state, local or foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require licensure or registration of pharmaceutical sales representatives; state laws that require disclosure of information related to drug pricing; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. • The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members in the applicable manufacturer, and disclosure of such information will be made by CMS on a publicly available website. • Analogous state, local or foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require licensure or registration of pharmaceutical sales representatives; state laws that require disclosure of information related to drug pricing; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA.
Obtaining requisite regulatory approval in any country is a complex, lengthy, expensive and uncertain process, and the FDA or the applicable foreign regulatory authority may delay, limit or deny approval of a Viaskin product, for many reasons, including, among others: • we may not be able to demonstrate that a product candidate is a safe and effective treatment, to the satisfaction of the FDA or the applicable foreign regulatory authority; • the results of our clinical trials or the clinical trials conducted by third party academic institutions and included in our application package may not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory authority for regulatory approval; • the FDA or the applicable foreign regulatory authority may disagree with the number, design, size, conduct or implementation of our clinical trials; • the FDA or the applicable foreign regulatory authority may require that we conduct additional clinical trials; • the FDA or the applicable foreign regulatory authority may not approve the formulation, labeling or specifications of a product candidate; • the clinical research organizations, or CROs, that we retain to conduct our clinical trials may take actions outside of our control that materially adversely impact our clinical trials; 51 • the FDA or the applicable foreign regulatory authority may find the data from pre-clinical studies and clinical trials from a product candidate insufficient to demonstrate that the clinical or other benefits of such product candidate outweighs its respective safety risks; • the FDA or the applicable foreign regulatory authority may disagree with our analysis or interpretation of data from our pre-clinical studies and clinical trials; • the FDA or the applicable foreign regulatory authority may not accept data generated at our clinical trial sites; • an advisory committee, or similar body, may recommend against approval of our application or may recommend that the FDA or the applicable foreign regulatory authority require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; • the FDA or the applicable foreign regulatory authority may require development or implementation of a Risk Evaluation and Mitigation Strategy(or REMS), or comparable foreign requirements, as a condition of approval or post-approval; • the FDA or the applicable foreign regulatory authority may restrict the use of our products to a narrow population; • the FDA or the applicable foreign regulatory authority may not approve the manufacturing processes or facilities of our own or of third-party manufacturers with which we contract, or may issue inspectional findings that require significant expense and time to address; or • the FDA or the applicable foreign regulatory authority may change their approval policies or new legislation governing the approval processes.
Obtaining requisite regulatory approval in any country is a complex, lengthy, expensive and uncertain process, and the FDA or the applicable foreign regulatory authority may delay, limit or deny approval of a Viaskin product, for many reasons, including, among others: • we may not be able to demonstrate that a product candidate is a safe and effective treatment, to the satisfaction of the FDA or the applicable foreign regulatory authority; • the results of our clinical trials or the clinical trials conducted by third party academic institutions and included in our application package may not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory authority for regulatory approval; • the FDA or the applicable foreign regulatory authority may disagree with the number, design, size, conduct or implementation of our clinical trials; • the FDA or the applicable foreign regulatory authority may require that we conduct additional clinical trials; • the FDA or the applicable foreign regulatory authority may not approve the formulation, labeling or specifications of a product candidate; • the clinical research organizations, or CROs, that we retain to conduct our clinical trials may take actions outside of our control that materially adversely impact our clinical trials; • the FDA or the applicable foreign regulatory authority may find the data from pre-clinical studies and clinical trials from a product candidate insufficient to demonstrate that the clinical or other benefits of such product candidate outweighs its respective safety risks; • the FDA or the applicable foreign regulatory authority may disagree with our analysis or interpretation of data from our pre-clinical studies and clinical trials; • the FDA or the applicable foreign regulatory authority may not accept data generated at our clinical trial sites; • an advisory committee, or similar body, may recommend against approval of our application or may recommend that the FDA or the applicable foreign regulatory authority require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; • the FDA or the applicable foreign regulatory authority may require development or implementation of a Risk Evaluation and Mitigation Strategy (or REMS), or comparable foreign requirements, as a condition of approval or post-approval; • the FDA or the applicable foreign regulatory authority may restrict the use of our products to a narrow population; • the FDA or the applicable foreign regulatory authority may not approve the manufacturing processes or facilities of our own or of third-party manufacturers with which we contract, or may issue inspectional findings that require significant expense and time to address; or • the FDA or the applicable foreign regulatory authority may change their approval policies or new legislation governing the approval processes.
Shares issued are registered in individual accounts opened by us or any authorized intermediary, in the 93 name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions; • approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause; • advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice; • our by-laws can be changed in accordance with applicable laws; • the crossing of certain thresholds has to be disclosed and can impose certain obligations; • transfers of shares shall comply with applicable insider trading rules and regulations and in particular with the Market Abuse Directive and Regulation dated April 16, 2014; and • pursuant to French law, the sections of the by-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by at least a two thirds majority vote of our shareholders present, represented by a proxy or voting by mail at the meeting.
Shares issued are registered in individual accounts opened by us or any authorized intermediary, in the name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions; • approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause; • advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice; • our by-laws can be changed in accordance with applicable laws; • the crossing of certain thresholds has to be disclosed and can impose certain obligations; • transfers of shares shall comply with applicable insider trading rules and regulations and in particular with the Market Abuse Directive and Regulation dated April 16, 2014; and • pursuant to French law, the sections of the by-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by at least a two thirds majority vote of our shareholders present, represented by a proxy or voting by mail at the meeting.
Furthermore, if we fail to comply with applicable FDA and other regulatory requirements at any stage during this regulatory process, we may encounter or be subject to: • issuance of warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available; • diminishment of any competitive advantages that such product candidates may have or attain; • suspension, delays or termination in clinical trials or commercialization; • delays or refusal by the FDA or similar foreign regulatory authorities to review pending applications for regulatory approval or supplements to approved applications; • voluntary or mandatory product recalls or seizures; • refusal to permit the import or export of medicinal products or intermediary chemicals; • suspension, restrictions or additional requirements on operations, including of manufacturing or revocation of necessary licenses; 55 • withdrawals, variations or suspensions of regulatory approvals; and • fines, civil penalties, and criminal prosecutions.
Furthermore, if we fail to comply with applicable FDA and other regulatory requirements at any stage during this regulatory process, we may encounter or be subject to: • issuance of warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available; • diminishment of any competitive advantages that such product candidates may have or attain; • suspension, delays or termination in clinical trials or commercialization; • delays or refusal by the FDA or similar foreign regulatory authorities to review pending applications for regulatory approval or supplements to approved applications; • voluntary or mandatory product recalls or seizures; • refusal to permit the import or export of medicinal products or intermediary chemicals; • suspension, restrictions or additional requirements on operations, including of manufacturing or revocation of necessary licenses; • withdrawals, variations or suspensions of regulatory approvals; and • fines, civil penalties, and criminal prosecutions.
The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United Kingdom, the European Union, the United States and other countries and companies and organizations against officials, individuals, regions, and industries in Russia and Ukraine, and actions taken by Russia in response to such sanctions, and responses of countries and 47 political bodies to such sanctions, tensions, and military actions and the potential for more widespread conflict, have resulted in supply chain disruptions, and resulting increases in inflation, financial market volatility and capital markets disruption, potentially increasing in magnitude, and such effects on the global economy and financial markets could affect our business, operations, operating results and financial condition as well as the price of our common stock and our ability to raise additional capital when needed on acceptable terms.
The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United Kingdom, the European Union, the United States and other countries and companies and organizations against officials, individuals, regions, and industries in Russia and Ukraine, and actions taken by Russia in response to such sanctions, and responses of countries and political bodies to such sanctions, tensions, and military actions and the potential for more widespread conflict, have resulted in supply chain disruptions, and resulting increases in inflation, financial market volatility and capital markets disruption, potentially increasing in magnitude, and such effects on the global economy and financial markets could affect our business, operations, operating results and financial condition as well as the price of our common stock and our ability to raise additional capital when needed on acceptable terms.
Further, if our Viaskin patch product candidates receive regulatory approval and we or others identify undesirable side effects caused by the products (or any 68 other similar products) after approval, a number of potentially significant negative consequences could result, including: • regulatory authorities may withdraw or limit their approval of the products; • regulatory authorities may require the addition of labeling statements, such as a “boxed” warning or a contraindication; • we may be required to change the way the products are distributed or administered, conduct additional clinical trials or change the labeling of the products; • we may decide to remove the products from the marketplace; • we could be sued and held liable for injury caused to individuals exposed to or taking our products; and • our reputation may suffer.
Further, if our Viaskin patch product candidates receive regulatory approval and we or others identify undesirable side effects caused by the products (or any other similar products) after approval, a number of potentially significant negative consequences could result, including: • regulatory authorities may withdraw or limit their approval of the products; • regulatory authorities may require the addition of labeling statements, such as a “boxed” warning or a contraindication; • we may be required to change the way the products are distributed or administered, conduct additional clinical trials or change the labeling of the products; • we may decide to remove the products from the marketplace; • we could be sued and held liable for injury caused to individuals exposed to or taking our products; and • our reputation may suffer.
Even if we contract with collaborators that successfully complete clinical trials for one or more of our product candidates, those candidates may not be commercialized for other reasons, including: • failing to receive regulatory approval to market them as drugs; • being subject to proprietary rights held by others; • failing to obtain approval from regulatory authorities on the manufacturing of our products; • being difficult or expensive to manufacture on a commercial scale; 61 • having adverse side effects that make their use less desirable; • failing to compete effectively with products or treatments commercialized by competitors; or • failing to show long-term risk/benefit ratio of our products.
Even if we contract with collaborators that successfully complete clinical trials for one or more of our product candidates, those candidates may not be commercialized for other reasons, including • failing to receive regulatory approval to market them as drugs; • being subject to proprietary rights held by others; • failing to obtain approval from regulatory authorities on the manufacturing of our products; • being difficult or expensive to manufacture on a commercial scale; • having adverse side effects that make their use less desirable; • failing to compete effectively with products or treatments commercialized by competitors; or • failing to show long-term risk/benefit ratio of our products.
Any legal action against us or our collaborators could lead to: • payment of damages, potentially treble damages, if we are found to have willfully infringed a party’s patent rights; 79 • injunctive or other equitable relief that may effectively block our ability to further develop, commercialize, and sell products; or • us or our collaborators having to enter into license arrangements that may not be available on commercially acceptable terms, if at all, all of which could have a material adverse impact on our cash position and business and financial condition.
Any legal action against us or our collaborators could lead to: • payment of damages, potentially treble damages, if we are found to have willfully infringed a party’s patent rights; • injunctive or other equitable relief that may effectively block our ability to further develop, commercialize, and sell products; or • us or our collaborators having to enter into license arrangements that may not be available on commercially acceptable terms, if at all, all of which could have a material adverse impact on our cash position and business and financial condition.
According to French law, if we issue additional securities for cash, current shareholders will have preferential subscription rights for these securities on a pro rata basis, transferable during a period starting two days prior to 94 the opening of the subscription period or, if that day is not a trading day, the preceding trading day; and ending two days prior to the closing of the subscription period or, of that day is not a trading day, the preceding trading day, unless they waive those rights at an extraordinary meeting of our shareholders (by a two-thirds majority vote) or individually by each shareholder.
According to French law, if we issue additional securities for cash, current shareholders will have preferential subscription rights for these securities on a pro rata basis, transferable during a period starting two days prior to the opening of the subscription period or, if that day is not a trading day, the preceding trading day; and ending two days prior to the closing of the subscription period or, of that day is not a trading day, the preceding trading day, unless they waive those rights at an extraordinary meeting of our shareholders (by a two-thirds majority vote) or individually by each shareholder.
Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including: • reliance on the third party for regulatory compliance and quality assurance; • the possible breach of the manufacturing agreement by the third party; 59 • the possible misappropriation of our proprietary information, including our trade secrets and know- how; and • the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.
Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including: • reliance on the third party for regulatory compliance and quality assurance; • the possible breach of the manufacturing agreement by the third party; • the possible misappropriation of our proprietary information, including our trade secrets and know-how; and • the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.
For example, any failure by a third-party processor to comply with applicable law, regulations, or contractual obligations including, providing appropriate notice to data subjects, obtaining necessary consents, or establishing a legal basis for the transfer and processing of the data by us, could result in 85 adverse effects, including inability to or interruption in our ability to operate our business and proceedings against us by governmental entities or others.
For example, any failure by a third-party processor to comply with applicable law, regulations, or contractual obligations including, providing appropriate notice to data subjects, obtaining necessary consents, or establishing a legal basis for the transfer and processing of the data by us, could result in adverse effects, including inability to or interruption in our ability to operate our business and proceedings against us by governmental entities or others.
The investor concerned could also be declared criminally liable and be sanctioned, in particular, by exclusion from any public contract or by a fine which may not exceed the highest of the following three amounts: (i) twice the amount of the investment concerned, (ii) 10% of the Company’s annual pre-tax revenues and (iii) 5 million euros (for a company) or 1 million euros (for an individual).
The investor concerned could also be declared criminally liable and be sanctioned, in particular, by exclusion from any public contract or by a fine which may not exceed the highest of the following three amounts: (i) twice the amount of the investment concerned, (ii) 10% of the Company’s annual pre-tax revenues and (iii) €5 million (for a company) or €1 million (for an individual).
These oral food challenge procedures can potentially trigger anaphylaxis or potentially life-threatening systemic allergic 53 reactions. Even though these procedures are well-controlled, standardized and performed in highly specialized centers with intensive care units, there are inherent risks in conducting a trial of this nature. An uncontrolled allergic reaction could potentially lead to serious or even fatal reactions.
These oral food challenge procedures can potentially trigger anaphylaxis or potentially life-threatening systemic allergic reactions. Even though these procedures are well-controlled, standardized and performed in highly specialized centers with intensive care units, there are inherent risks in conducting a trial of this nature. An uncontrolled allergic reaction could potentially lead to serious or even fatal reactions.
The FDA and 57 comparable foreign regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if we, or our collaborators, market any of our product candidates for which we, or they, receive regulatory approval for treatment other than their approved indications, we, or they, may be subject to warnings or enforcement action for off-label marketing.
The FDA and comparable foreign regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if we, or our collaborators, market any of our product candidates for which we, or they, receive regulatory approval for treatment other than their approved indications, we, or they, may be subject to warnings or enforcement action for off-label marketing.
Health Technology Assessment, or HTA, of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including those representing the larger markets. The HTA process is the procedure to assess therapeutic, economic and societal impact of a given medicinal product in the national healthcare systems of the individual country.
This Health Technology Assessment, or HTA, of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including those representing the larger markets. The HTA process is the procedure to assess therapeutic, economic and societal impact of a given medicinal product in the national healthcare systems of the individual country.
If we cannot successfully negotiate sufficient ownership and commercial rights to the inventions that result from our use of a third-party collaborator’s materials where required, or if disputes otherwise arise with respect to the intellectual property developed with the use of a collaborator’s samples, we may be limited in our ability to capitalize on the market potential of these inventions.
If we cannot successfully negotiate sufficient ownership and commercial rights to the inventions that result from our use of a third-party collaborator’s materials where required, or if disputes otherwise arise with respect to the intellectual property developed with the use of a collaborator’s materials, we may be limited in our ability to capitalize on the market potential of these inventions.
There can be no assurance that any country that has price controls or reimbursement limitations for biopharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, biopharmaceutical products launched in the European Union do not follow price structures 67 of the United States and generally tend to have significantly lower prices.
There can be no assurance that any country that has price controls or reimbursement limitations for biopharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, biopharmaceutical products launched in the European Union do not follow price structures of the United States and generally tend to have significantly lower prices.
Accordingly, it is not clear what, if any, impact the America Invents Act will have on the cost of prosecuting our patent applications, our ability to obtain patents based on our discoveries and our ability to enforce or defend any patents that may issue from our patent applications, all of which could have a material adverse effect on our business.
Accordingly, it is still not clear what, if any, impact the America Invents Act will have on the cost of prosecuting our patent applications, our ability to obtain patents based on our discoveries and our ability to enforce or defend any patents that may issue from our patent applications, all of which could have a material adverse effect on our business.
On December 20, 2023, we received a letter from the Listing Qualifications Staff of Nasdaq notifying the us that for the last 30 consecutive business days, the bid price of our ADSs had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2).
For instance, on December 20, 2023, we received a letter from the Listing Qualifications Staff of Nasdaq notifying the us that for the last 30 consecutive business days, the bid price of our ADSs had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2).
In addition, over the past few years, bills in the U.S. Congress have bene proposed that, if passed, would make changes to the America Invents Act. For example, bills have been introduced that would reduce the discretion of the Patent Trial and Appeal Board (PTAB) to deny some or all post-grant proceedings.
In addition, over the past few years, bills in the U.S. Congress have been proposed that, if passed, would make changes to the America Invents Act. For example, bills have been introduced that would reduce the discretion of the Patent Trial and Appeal Board (PTAB) to deny some or all post-grant proceedings.
This may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Any physical expansion of our operations may lead to significant 88 costs and may divert financial resources from other projects, such as the development of our product candidates.
This may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Any physical expansion of our operations may lead to significant costs and may divert financial resources from other projects, such as the development of our product candidates.
If we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering our product candidate, the defendant could counterclaim that the patent covering our product candidate is invalid 80 and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace.
If we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering our product candidate, the defendant could counterclaim that the patent covering our product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace.
If some investors find our ADSs less attractive as a result, there may be a less active trading market for our ADSs and our ADS price may be more volatile. 97 U.S. holders may suffer adverse tax consequences if we are characterized as a passive foreign investment company. Under the U.S.
If some investors find our ADSs less attractive as a result, there may be a less active trading market for our ADSs and our ADS price may be more volatile. U.S. holders may suffer adverse tax consequences if we are characterized as a passive foreign investment company. Under the U.S.
These and other market and industry factors may cause the market price and demand for our securities to fluctuate substantially, regardless of our actual operating 89 performance, which may limit or prevent investors from readily selling their ADSs or ordinary shares and may otherwise negatively affect the liquidity of our ADSs and ordinary shares.
These and other market and industry factors may cause the market price and demand for our securities to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their ADSs or ordinary shares and may otherwise negatively affect the liquidity of our ADSs and ordinary shares.
We currently have no drug or biological product approved for sale and may never be able to develop a marketable drug or biological product. 50 We may not be successful in developing and commercializing Viaskin Peanut and our other product candidates, including, without limitation, Viaskin Milk, and our commercial opportunities may be limited.
We currently have no drug or biological product approved for sale and may never be able to develop a marketable drug or biological product. We may not be successful in developing and commercializing Viaskin Peanut and our other product candidates, including, without limitation, Viaskin Milk, and our commercial opportunities may be limited.
From time to time, the United States Supreme Court, the United States Court of Appeals for the Federal Circuit, other federal courts, the United States Congress, the USPTO or similar foreign authorities may change the 76 standards of patentability and any such changes could have a negative impact on our business.
From time to time, the United States Supreme Court, the United States Court of Appeals for the Federal Circuit, other federal courts, the United States Congress, the USPTO or similar foreign authorities may change the standards of patentability and any such changes could have a negative impact on our business.
In addition, data privacy and security laws have been proposed at the federal, state, and local levels in recent years, which could further complicate compliance efforts. 84 Outside the United States, an increasing number of laws, regulations, and industry standards apply to data privacy and security.
In addition, data privacy and security laws have been proposed at the federal, state, and local levels in recent years, which could further complicate compliance efforts. Outside the United States, an increasing number of laws, regulations, and industry standards apply to data privacy and security.
For example, under the EU GDPR, government regulators may impose temporary or definitive bans on data processing, as well as fines of up to 20 million euros or 4% of the total annual global revenue of the preceding year, whichever is greater.
For example, under the EU GDPR, government regulators may impose temporary or definitive bans on data processing, as well as fines of up to €20 million or 4% of the total annual global revenue of the preceding year, whichever is greater.
Additionally, it may be difficult to assert U.S. securities law claims in actions originally instituted outside of the United States. Foreign courts may refuse to hear a U.S. securities law claim because foreign courts may not be the most appropriate forums in which to bring such a 96 claim.
Additionally, it may be difficult to assert U.S. securities law claims in actions originally instituted outside of the United States. Foreign courts may refuse to hear a U.S. securities law claim because foreign courts may not be the most appropriate forums in which to bring such a claim.
The FDA also indicated that supplementary clinical data would need to be generated to support applications for both the Type IV Viaskin Peanut System (the original Viaskin Peanut system), or cVP, and the Type V Viaskin Peanut System (the modified Viaskin Peanut System), or mVP, and requested additional Chemistry, Manufacturing and Controls, or CMC, data.
The FDA also indicated that supplementary clinical data would need to be generated to support applications for both the Type IV Viaskin Peanut System , or cVP, and the Type V Viaskin Peanut System (the modified Viaskin Peanut System), or mVP, and requested additional Chemistry, Manufacturing and Controls, or CMC, data.
We have written agreements with collaborators that provide for the ownership of intellectual property 78 arising from our collaborations. These agreements provide that we may have to negotiate certain commercial rights with collaborators with respect to joint inventions or inventions made by our collaborators that arise from the results of the collaboration.
We have written agreements with collaborators that provide for the ownership of intellectual property arising from our collaborations. These agreements provide that we may have to negotiate certain commercial rights with collaborators with respect to joint inventions or inventions made by our collaborators that arise from the results of the collaboration.
Severe ransomware attacks, including by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions in our 86 operations, loss of data and income, reputational harm, and diversion of funds.
Severe ransomware attacks, including by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions in our operations, loss of data and income, reputational harm, and diversion of funds.
Depending on the results of clinical trials and the process for obtaining 56 regulatory approvals in other countries, we may decide to first seek regulatory approvals of a product candidate in countries other than the United States, or we may simultaneously seek regulatory approvals in the United States and other countries.
Depending on the results of clinical trials and the process for obtaining regulatory approvals in other countries, we may decide to first seek regulatory approvals of a product candidate in countries other than the United States, or we may simultaneously seek regulatory approvals in the United States and other countries.
We are subject to the reporting requirements of the Securities 49 Exchange Act of 1934, or the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements and other applicable securities rules and regulations.
We are subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements and other applicable securities rules and regulations.
We rely on a single supplier to produce, or contract for the production of, active ingredients and we rely on a single manufacturer to produce patches for our clinical trials and for our commercial supplies of any future 60 approved products.
We rely on a single supplier to produce, or contract for the production of, active ingredients and we rely on a single manufacturer to produce patches for our clinical trials and for our commercial supplies of any future approved products.
Employee misconduct could also involve the improper use of, including trading on, 81 information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.
Employee misconduct could also involve the improper use of, including trading on, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.
Individual EU Member States will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement.
Individual EU Member States continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement.
If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or 77 misappropriated, or if any such information was independently developed by a competitor, our competitive position could be harmed.
If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, our competitive position could be harmed.
The supply of these materials could be reduced or interrupted at any time, including, without limitation, as a result of impacts due to pandemics, epidemics or other global health crises, natural disasters, new laws or regulations applicable to us or our suppliers, or other unfavorable global economic conditions, including as a result of the ongoing conflict between Russia-Ukraine, Irael-Hamas and other global political or military conflicts.
The supply of these materials could be reduced or interrupted at any time, including, without limitation, as a result of impacts due to pandemics, epidemics or other global health crises, natural disasters, new laws or regulations applicable to us or our suppliers, or other unfavorable global economic conditions, including as a result of the ongoing conflict between Russia-Ukraine, Israel-Hamas and other global political or military conflicts.
Our ability to obtain patent protection for our product candidates is uncertain due to a number of factors, including: • we may not have been the first to make the inventions covered by pending patent applications or issued patents; • we may not have been the first to file patent applications for our product candidates or the compositions we developed or for their uses; • others may independently develop identical, similar or alternative products or compositions and uses thereof; • our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability; • any or all of our pending patent applications may not result in issued patents; • we may not seek or obtain patent protection in countries that may eventually provide us a significant business opportunity; • any patents issued to us may not protect, encompass, or embody commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties; • our compositions and methods may not be patentable; • others may design around our patent claims to produce competitive products which fall outside of the scope of our patents; or • others may identify prior art or other bases which could invalidate our patents.
Our ability to obtain and/or maintain patent protection for our product candidates is uncertain due to a number of factors, including: • we may not have been the first to make the inventions covered by pending patent applications or issued patents; • we may not have been the first to file patent applications for our product candidates or the compositions we developed or for their uses; • others may independently develop identical, similar or alternative products or compositions and uses thereof; • our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability; • any or all of our pending patent applications may not result in issued patents; • we may not seek or obtain patent protection in countries that may eventually provide us a significant business opportunity; • any patents issued to us may not protect, encompass, or embody commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties; • our compositions and methods may not be patentable; • others may design around our patent claims to produce competitive products which fall outside of the scope of our patents; • our issued patents could potentially be found to be unenforceable; or • others may identify prior art or other bases which could invalidate our patents.
Because the determination of our PFIC status is based on complicated provisions of the Code and applicable administrative authorities, there can be no assurance that our conclusions concerning our PFIC status for the taxable year ending December 31, 2022 are correct and will not be successfully challenged by applicable tax authorities, and we cannot provide any assurance regarding our PFIC status for the current taxable year or any future taxable year.
Because the determination of our PFIC status is based on complicated provisions of the Code and applicable administrative authorities, there can be no assurance that our conclusions concerning our PFIC status for the taxable year ending December 31, 2023 are correct and will not be successfully challenged by applicable tax authorities, and we cannot provide any assurance regarding our PFIC status for the current taxable year or any future taxable year.
Share ownership is concentrated in the hands of our principal shareholders and management, who will continue to be able to exercise a direct or indirect controlling influence on us. As of December 31, 2023, our executive officers, directors, current 5% or greater shareholders and affiliated entities, including entities affiliated with Baker Bros.
Share ownership is concentrated in the hands of our principal shareholders and management, who will continue to be able to exercise a direct or indirect controlling influence on us. As of December 31, 2024, our executive officers, directors, current 5% or greater shareholders and affiliated entities, including entities affiliated with Baker Bros.
On February 16 2024, the FDA approved Xolair ® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.
In February 2024, the FDA approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.
Delisting would also likely have a negative effect on the price of our ADS s, would affect our ability to raise additional capital through the public or private sale of equity securities , and would impair your ability to sell or purchase our ADSs when you wish to do so.
Delisting would also likely have a negative effect on the price of our ADSs, would affect our ability to raise additional capital through the public or private sale of equity securities, and would impair your ability to sell or purchase our ADSs when you wish to do so.
To date, more than twelve clinical trials of Viaskin Peanut and Viaskin Milk product candidates have been conducted both outside and inside of the United States in over 1,000 human subjects to evaluate the safety and efficacy of these product candidates for the treatment of peanut allergies and milk allergies, respectively.
To date, more than twelve clinical trials of Viaskin Peanut and Viaskin Milk product candidates have been conducted both outside and inside of the United States in over 2,000 human subjects to evaluate the safety and efficacy of these product candidates for the treatment of peanut allergies and milk allergies, respectively.
The commencement and completion of clinical trials for our product candidates may be delayed, suspended or terminated due to a number of factors, including: • lack of effectiveness of product candidates during clinical trials; • adverse events, safety issues or side effects relating to the product candidates or their formulation; • serious adverse events relating to the double-blind, placebo-controlled food challenge procedure when testing participants for the sensitivity of their allergies; • inability to raise additional capital in sufficient amounts to continue clinical trials or development programs, which are very expensive; • the need to sequence clinical trials as opposed to conducting them concomitantly in order to conserve resources; • our inability to enter into collaborations relating to the development and commercialization of our product candidates; • failure by us or our collaborators to conduct clinical trials in accordance with regulatory requirements; 54 • our inability or the inability of our collaborators to manufacture or obtain from third parties materials sufficient for use in pre-clinical studies and clinical trials; • governmental or regulatory delays, changes by regulatory agencies, including, without limitation, unexpected changes, unrelated to new developments of the science, in prior guidance and instruction provided to us, changes in regulatory requirements, policy and guidelines, and mandated changes in the scope or design of clinical trials or requests for supplemental information with respect to clinical trial results; • failure of our collaborators to advance our product candidates through clinical development; • delays in enrollment, variability in the number and types of subjects available for clinical trials, and lower-than anticipated retention rates for subjects in clinical trials; • difficulty in subject monitoring and data collection due to failure of subjects to maintain contact after treatment; • a regional disturbance where we or our collaborative partners are enrolling patients in our clinical trials, such as the COVID-19 pandemic or any other pandemics, epidemics, or global health crises, terrorist activities or war, or a natural disaster; and • varying interpretations of our data, and regulatory commitments and requirements by the FDA and similar foreign regulatory authorities.
The commencement and completion of clinical trials for our product candidates may be delayed, suspended or terminated due to a number of factors, including: • lack of effectiveness of product candidates during clinical trials; • adverse events, safety issues or side effects relating to the product candidates or their formulation; • serious adverse events relating to the double-blind, placebo-controlled food challenge procedure when testing participants for the sensitivity of their allergies; • inability to provide clinical supplies or product candidate necessary for the conduct of clinical trials due to shortages or unavailability; • delays in lab testing of product candidates required for release for use in clinical trials; • inability to raise additional capital in sufficient amounts to continue clinical trials or development programs, which are very expensive; • the need to sequence clinical trials as opposed to conducting them concomitantly in order to conserve resources; • our inability to enter into collaborations relating to the development and commercialization of our product candidates; • failure by us or our collaborators to conduct clinical trials in accordance with regulatory requirements; • our inability or the inability of our collaborators to manufacture or obtain from third parties materials sufficient for use in pre-clinical studies and clinical trials; • governmental or regulatory delays, changes by regulatory agencies, including, without limitation, unexpected changes, unrelated to new developments of the science, in prior guidance and instruction provided to us, changes in regulatory requirements, policy and guidelines, and mandated changes in the scope or design of clinical trials or requests for supplemental information with respect to clinical trial results; • failure of our collaborators to advance our product candidates through clinical development; • delays in enrollment, variability in the number and types of subjects available for clinical trials, and lower-than anticipated retention rates for subjects in clinical trials; • difficulty in subject monitoring and data collection due to failure of subjects to maintain contact after treatment; • a regional disturbance where we or our collaborative partners are enrolling patients in our clinical trials, such as the COVID-19 pandemic or any other pandemics, epidemics, or global health crises, terrorist activities or war, or a natural disaster; and • varying interpretations of our data, and regulatory commitments and requirements by the FDA and similar foreign regulatory authorities.
The completion of any investment (i) by (a) an individual of foreign nationality, (b) any individual of French nationality not domiciled in France within the meaning of article 4B of the French General Tax Code ( Code Général des Impôts ), (c) any entity governed by foreign law, and (d) any entity governed by French law controlled by one or more of the entities referred to in (a) to (c), (ii) which would result in (a) the acquisition of control—within the meaning of article L. 233-3 of the French Commercial Code (Code de Commerce)—of a French company, (b) the acquisition of all or part of a branch of activity of a French company, or (c) for individuals who are not nationals of a Member State of the European Union or of a State party to the agreement on the European Economic Area that has entered into an administrative assistance agreement with France and/or are not domiciled in one of these States, or for legal entities of which at least one of the members of the control chain is not governed by the law of one of these States or is not a national and/or is not domiciled there, to cross the threshold of 25% of the voting rights of a French company, or (d) for individuals who are not nationals of a Member State of the EU or of a State party to the agreement on the EEA that has entered into an administrative assistance agreement with France and/or are not domiciled in one of these State, or for legal entities of which at least one of the members of the control chain is not governed by the law of one of these States or is not a national and/or is not domiciled there, to cross the threshold of 10% of the voting rights of a French company whose shares are admitted to trading on a regulated market and (iii) whose activities concern, even occasionally, the research and development of so-called critical technologies, such as biotechnologies, and considered essential to the protection of public health, is subject to prior authorization by the French Minister of the Economy ( Ministère de l’Economie ).
The completion of any investment (i) by (a) an individual of foreign nationality, (b) any individual of French nationality not domiciled in France within the meaning of article 4B of the French General Tax Code ( Code général des impôt s), (c) any entity governed by foreign law, and (d) any entity governed by French law controlled by one or more of the entities referred to in (a) to (c), (ii) which would result in (a) the acquisition of control—within the meaning of article L. 233-3 of the French Commercial Code ( Code de commerce )—of a French company, (b) the acquisition of all or part of a branch of activity of a French company, or (c) for individuals who are not nationals of a Member State of the European Union or of a State party to the agreement on the European Economic Area that has entered into an administrative assistance agreement with France and/or are not domiciled in one of these States, or for legal entities of which at least one of the members of the control chain is not governed by the law of one of these States or is not a national and/or is not domiciled there, to cross the threshold of 25% of the voting rights of a French company, or (d) for individuals who are not nationals of a Member State of the EU or of a State party to the agreement on the EEA that has entered into an administrative assistance agreement with France and/or are not domiciled in one of these State, or for legal entities o f which at least one of the members of the control chain is not governed by the law of one of these States or is not a national and/or is not domiciled there, to cross the threshold of 10% of the voting rights of a French company whose shares are admitted to trading on a regulated market and (iii) whose activities concern, even occasionally, the research and development of so-called critical technologies, such as biotechnologies, and considered essential to the protection of public health, is subject to prior authorization by the French Minister of the Economy (ministère de l’Économie ).
All of these milestones are based on a variety of assumptions which may cause the timing of achievement of the milestones to vary considerably from our estimates, including: • our available capital resources or capital constraints we experience; • our receipt of approvals, if any, by the FDA and other comparable foreign regulatory authorities and the timing thereof; • the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators, and our ability to identify and enroll patients who meet clinical trial eligibility criteria; • other actions, decisions or rules issued by regulators; • our ability to access sufficient, reliable and affordable supplies of compounds used in the manufacture of our product candidates; • the efforts of our collaborators with respect to the commercialization of our products; and • the securing of, costs related to, and timing issues associated with, product manufacturing, as well as sales and marketing activities.
All of these milestones are based on a variety of assumptions which may cause the timing of achievement of the milestones to vary considerably from our estimates, including: • our available capital resources or capital constraints we experience; • our ability to pursue Accelerated Approval or any other actionable regulatory pathway for our product candidates; • our receipt of approvals, if any, by the FDA and other comparable foreign regulatory authorities and the timing thereof; • the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators, and our ability to identify and enroll patients who meet clinical trial eligibility criteria; • other actions, decisions or rules issued by regulators; • our ability to access sufficient, reliable and affordable supplies of compounds used in the manufacture of our product candidates; • the efforts of our collaborators with respect to the commercialization of our products; and • the securing of, costs related to, and timing issues associated with, product manufacturing, as well as sales and marketing activities.
For any taxable year in which we are a PFIC, we will determine whether we will provide to U.S. holders the information required to make a QEF election; for the taxable year ending December 31, 2023, we have provided that information.
For any taxable year in which we are a PFIC, we will determine whether we will provide to U.S. holders the information required to make a QEF election; for the taxable year ending December 31, 2024, we have provided that information.
In the European Union, there is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product. For such products, the results of appropriate preclinical or clinical trials must be provided in support of an application for Marketing Authorization.
In the European Union, there is also a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product. For such products, the results of appropriate preclinical or clinical trials must be provided in support of a related application for Marketing Authorization.
For example, recently the federal courts and the United States Supreme Court have issued (and may issue additional) rules generally related to standards for upholding the validity of biological and chemical “genus” claims.
For example, recently the federal courts and the United States Supreme Court have issued (and may issue additional) rulings generally related to standards for upholding the validity of biological and chemical “genus” claims.
Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, inter partes review, and equivalent proceedings in foreign jurisdictions, e.g., opposition proceedings.
Third parties may also raise similar claims regarding invalidity and/or unenforceability before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, inter partes review, and equivalent proceedings in foreign jurisdictions, e.g., opposition proceedings.
If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our ADSs could be delisted. Our ADSs are currently listed on The Nasdaq Global Market.
If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our ADSs could be delisted. Our ADSs are currently listed on The Nasdaq Capital Market.
Based on the composition of our gross income and the nature and composition of our gross assets, we believe that we may have been a PFIC for the taxable year ending December 31, 2023.
Based on the composition of our gross income and the nature and composition of our gross assets, we believe that we may have been a PFIC for the taxable year ending December 31, 2024.
The overall ten-year period may, occasionally, be extended for a further year to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
The overall ten-year period may, occasionally, be extended for a further year to a maximum of 11 years if, during the first eight years following authorization of the reference product, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
Our ADSs are traded on the Nasdaq Global Select Market, and our ordinary shares are listed on Euronext Paris. The dual listing of our ordinary shares and our ADSs may dilute the liquidity of these securities in one or both markets and may adversely affect the maintenance of an active trading market for our ADSs in the United States.
Our ADSs are traded on the Nasdaq Capital Market, and our ordinary shares are listed on Euronext Paris. The dual listing of our ordinary shares and our ADSs may dilute the liquidity of these securities in one or both markets and may adversely affect the maintenance of an active trading market for our ADSs in the United States.
We will need to develop and implement sales, marketing and distribution capabilities before we are able to bring any product candidate to market, and as a result, we may encounter difficulties in managing this development and expansion, which could disrupt our operations. As of December 31, 2023, we had 104 full-time employees.
We will need to develop and implement sales, marketing and distribution capabilities before we are able to bring any product candidate to market, and as a result, we may encounter difficulties in managing this development and expansion, which could disrupt our operations. As of December 31, 2024, we had 109 full-time employees.
Any future public health crises could materially affect our operations as well as cause significant disruption in the operations and business of third-party manufacturers, CROs, other services providers, and collaborators with whom we conduct business. It is impossible to predict all effects and the ultimate impact of any public health crises, including the COVID-19 pandemic.
Any future public health crises could materially affect our operations as well as cause significant disruption in the operations and business of third-party manufacturers, CROs, other services providers, and collaborators with whom we conduct business. It is impossible to predict all effects and the ultimate impact of any public health crises.
The EU Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. The CTR allows sponsors to make a single 72 submission to both the competent authority and an ethics committee in each EU Member State, leading to a single decision for each EU Member State.
The EU Clinical Trials Regulation (“CTR”), which was adopted in April 2014 and repeals the EU Clinical Trials Directive (“CTD”), became applicable on January 31, 2022. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each EU Member State, leading to a single decision for each EU Member State.
Collaborations involving our product candidates pose a number of risks, including the following: • collaborators may not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as budget limitations, lack of human resources, or a change in strategic focus; • collaborators may believe our intellectual property is not valid, is not infringed by potential competitors or is unenforceable or the product candidate infringes on the intellectual property rights of others; • collaborators may dispute their responsibility to conduct development and commercialization activities pursuant to the applicable collaboration, including the payment of related costs or the division of any revenues; • collaborators may decide to pursue a competitive product developed outside of the collaboration arrangement; • collaborators may not be able to obtain, or believe they cannot obtain, the necessary regulatory approvals; or • collaborators may delay the development or commercialization of our product candidates in favor of developing or commercializing another party’s product candidate. 74 Thus, collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all.
Collaborations involving our product candidates pose a number of risks, including the following: • collaborators may not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as budget limitations, lack of human resources, or a change in strategic focus; • collaborators may believe our intellectual property is not valid, is not infringed by potential competitors or is unenforceable or the product candidate infringes on the intellectual property rights of others; • collaborators may dispute their responsibility to conduct development and commercialization activities pursuant to the applicable collaboration, including the payment of related costs or the division of any revenues; • collaborators may decide to pursue a competitive product developed outside of the collaboration arrangement; • collaborators may not be able to obtain, or believe they cannot obtain, the necessary regulatory approvals; or • collaborators may delay the development or commercialization of our product candidates in favor of developing or commercializing another party’s product candidate.
On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.
For example, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.
According to French law, as of December 31, 2023 we have issued : - 28,276,331 pre-funded warrants at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), Each pre-funded warrant bears an exercise price of €0.10 per Warrant Share; - Restricted Stock Units (“RSU”), stock options plan (“SO”), and non-employee warrants (Bons de Souscription d’Actions i.e.
According to French law, as of December 31, 2024 we have issued: • 22,266,331 pre-funded warrants at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), Each pre-funded warrant bears an exercise price of €0.10 per Warrant Share; • Restricted Stock Units (“RSU”), stock options plan (“SO”), and non-employee warrants ( bons de souscription d’actions i.e.
We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our financial condition, results of operations and cash flows. The ADSs are quoted in U.S. dollars on the Nasdaq Global Select Market and our ordinary shares are trading in euros on Euronext Paris.
We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our financial condition, results of operations and cash flows. The ADSs are quoted in U.S. dollars on the Nasdaq Capital Market and our ordinary shares are trading in euros on Euronext Paris. Our financial statements are prepared in euros.
Data exclusivity, if granted, prevents regulatory authorities in the European Union from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product, after which a generic or biosimilar marketing authorization application can be submitted, and the innovator’s data may be referenced.
Data exclusivity, if granted, prevents regulatory authorities in the European Union from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product. After this period, an application for marketing authorization for a generic or biosimilar product may be submitted, and the innovator’s data may be referenced.
Earthquakes, other natural disasters or an outbreak of a contagious disease, such as COVID-19, could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects.
Earthquakes, other natural disasters or an outbreak of a contagious disease could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects.
In addition, our expenses could increase beyond expectations if the FDA requires us to perform nonclinical studies, clinical trials or post-approval clinical trials for our approved products, if any, in addition to those that we currently anticipate. As of December 31, 2023, our cash and cash equivalents were $141.4 million.
In addition, our expenses could increase beyond expectations if the FDA requires us to perform nonclinical studies, clinical trials or post-approval clinical trials for our approved products, if any, in addition to those that we currently anticipate. As of December 31, 2024, our cash and cash equivalents were $32.5 million.
In addition, the recession or resulting adverse impacts on the capital markets resulting from the COVID-19 pandemic, and any future public health crises, could materially affect our business. The U.S. Federal Reserve recently raised interest rates multiple times in response to concerns about inflation and it may raise them again.
In addition, the recession or resulting adverse impacts on the capital markets resulting from any future public health crises, could materially affect our business. The U.S. Federal Reserve has in recent years raised interest rates multiple times in response to concerns about inflation and it may raise them again.
Moreover, eligibility for coverage and reimbursement does not imply that a product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sales and distribution. Third-party payors are increasingly reducing reimbursements for medical products, drugs and services.
Moreover, eligibility for coverage and reimbursement does not imply that a product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sales and distribution. Third-party payors are increasingly reducing reimbursements for medical products, drugs and services. Further, coverage policies and third-party reimbursement rates may change at any time.
The Regulation foresees a three-year transitional period and will permit EU Member States to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.
The Regulation permits EU Member States to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.
Because patent applications can take many years to issue as patents, and because there can be procedures to keep some applications secret, there may be currently pending applications unknown to us that may later result in issued patents that our product candidates or compositions may infringe.
Because patent applications can take many years to issue as patents, and because there can be procedures to keep some applications secret, there may be currently pending applications unknown to us that may later result in issued patents that our product candidates or compositions may infringe. These patent applications may have priority over patent applications filed by us.
In addition, the combined shareholders’ meeting dated April 12, 2023 granted authority to our board of directors to increase our share capital up to 100% of issued share capital, if the investors in such offering fit within categories of persons meeting certain characteristics.
In addition, the combined shareholders’ meeting dated May 16, 2024 granted authority to our board of directors to increase our share capital up to 100% of issued share capital, if the investors in such offering fit within categories of persons meeting certain characteristics.
These factors could harm the value of the ADSs, and, in turn, the U.S. dollar proceeds that holders receive from the sale of the ADSs. Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs. As of December 31, 2023, 96,431,770 ordinary shares were issued and outstanding.
These factors could harm the value of the ADSs, and, in turn, the U.S. dollar proceeds that holders receive from the sale of the ADSs. Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs. As of December 31, 2024, 102,847,501 ordinary shares were issued and outstanding.
With regard to biopharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare prescription drug benefit. However, there have been executive, judicial and Congressional 65 challenges to certain aspects of the ACA. For example, on June 17, 2021 the U.S.
With regard to biopharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare prescription drug benefit. However, there have been amendments to and executive, judicial and Congressional challenges to certain aspects of the ACA.
Even if regulatory approval of a product candidate is granted, the approval will be subject to limitations on the indicated uses for which the product may be marketed or may be subject to other conditions of approval, including the FDA requirement to implement a REMS, or comparable foreign requirements to ensure that the benefits of a drug or biological product outweigh its risks.
Even if regulatory approval of a product candidate is granted, the approval will be subject to limitations on the indicated uses for which the product may be marketed or may be subject to other conditions of approval, including, without limitation, FDA requirement that we pre-clear all promotional materials with the agency and the FDA requirement to implement a REMS, or comparable foreign requirements to ensure that the benefits of a drug or biological product outweigh its risks.
Due to our limited financial resources, an unfavorable outcome in one or more trials may require us to delay, reduce the scope of, or eliminate one or more product development programs, which could have a material adverse effect on our business and financial condition and on the value of our ADSs and ordinary shares. 52 In connection with clinical testing and trials, we face a number of risks, including, but not limited to: • a product candidate is ineffective, inferior to existing approved medicines or treatment options, unacceptably toxic, or has unacceptable side effects; • patients may die or suffer other adverse effects for reasons that may or may not be related to the product candidate being tested, especially during the double-blind, placebo-controlled food challenges; • extension studies on long-term tolerance could invalidate the use of our product, showing Viaskin does not generate a sustained protective effect; • any positive results of earlier testing or trials may not be confirmed by results of subsequent trials; and • the results may not meet the level of statistical significance required by the FDA or other comparable regulatory authorities to establish the safety and efficacy of our product candidates.
In connection with clinical testing and trials, we face a number of risks, including, but not limited to: • a product candidate is ineffective, inferior to existing approved medicines or treatment options, unacceptably toxic, or has unacceptable side effects; • patients may die or suffer other adverse effects for reasons that may or may not be related to the product candidate being tested, especially during the double-blind, placebo-controlled food challenges; • extension studies on long-term tolerance could invalidate the use of our product, showing Viaskin does not generate a sustained protective effect; • any positive results of earlier testing or trials may not be confirmed by results of subsequent trials; and • the results may not meet the level of statistical significance required by the FDA or other comparable regulatory authorities to establish the safety and efficacy of our product candidates.
In addition, the IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs and biologics under the law, and (ii) imposes rebates with respect to certain drugs and biologics covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation.
At the federal level, the IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-sourcebiologics that have been on the market for at least 11 years covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs and biologics under the law, or the “Medicare Drug Price Negotiation Program”, and (ii) imposes rebates with respect to certain drugs and biologics covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation.
It is unclear how such challenges and the healthcare reform measures of the Biden administration will impact the ACA or operations. Following ACA, both the Budget Control Act of 2011 and the American Taxpayer Relief Act of 2012, or the ATRA, include, among other things, mandatory reductions in Medicare payments to certain providers.
It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the ACA or operations. Following ACA, both the Budget Control Act of 2011 includes, among other things, mandatory reductions in Medicare payments to certain providers.

… 140 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

4 edited+0 added−0 removed13 unchanged
Biggest changeOur cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including Cyril Guyardeau, our Director of Information Systems Security, who had previously spent 15 years as an IT infrastructure engineer in the healthcare industry, and Cecile Delansorne, our 99 Vice President for Information Systems, who has held similar executive positions overseeing information systems in other pharmaceutical companies for over 7years.
Biggest changeOur cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including, but not limited to, Cyril Guyardeau, our Director of Information Systems Security, who had previously spent 15 years as an IT infrastructure engineer in the healthcare industry, and Cecile Delansorne, our Vice President for Information Systems, who has held similar executive positions overseeing information systems in other pharmaceutical companies for over seven years.
The cybersecurity component of the Company’s risk mapping and management documentation is updated annually, and our Information Systems function, led by our Vice President for Information Systems and Director of Information Systems, prepares cybersecurity roadmaps designed to prioritize our risk management processes and mitigate cybersecurity threats that are more likely to lead to a material impact to our business.
The cybersecurity component of the Company’s risk mapping and management documentation is updated annually, and our Information Systems security function, led by our Vice President for Information Systems and Director of Information Systems security, prepares cybersecurity roadmaps designed to prioritize our risk management processes and mitigate cybersecurity threats that are more likely to lead to a material impact to our business.
Our 98 Information Systems function identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods including, for example automated tools, subscribing to and analyzing reports and services that identify cybersecurity threats, conducting scans of the Company’s threat environment, evaluating threats that are reported to us, conducting internal audits, internal threat assessments, and conducting vulnerability assessments.
Our Information Systems security function identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods including, for example automated tools, subscribing to and analyzing reports and services that identify cybersecurity threats, conducting scans of the Company’s threat environment, evaluating threats that are reported to us, conducting internal audits, internal threat assessments, and conducting vulnerability assessments.
Our Information Systems function, led by our Vice President for Information Systems and Director of Information Systems, helps identify, assess and manage the Company’s cybersecurity threats and risks.
Our Information Systems security function, led by our Vice President for Information Systems and Director of Information Systems security, helps identify, assess and manage the Company’s cybersecurity threats and risks.

Item 2. Properties

Properties — owned and leased real estate

2 edited+2 added−1 removed0 unchanged
Biggest changeOn March 28, 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 5,799 square feet in Basking Ridge, New Jersey. We consider our facilities to be suitable and adequate for the management and operation of our business.
Biggest changeIn April 2022, we entered into a lease agreement for a 5,799 square foot office in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months, expiring April 30, 2025. We consider our facilities to be suitable and adequate for the management and operation of our business.
Item 2. Properties. Our corporate headquarters are located in Montrouge, France. Our principal office occupies a 4,470 square meter facility, pursuant to a lease agreement, signed on March 3, 2015, with an effective date of August 1, 2015 and which expires on July 31, 2024.
Item 2. Properties. Our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023, which commenced as of April 16, 2024 with an expiration in March 2033.
Removed
The company leased a commercial facility in Chatillon, France with early availability of the premises from November , 2023 and commencement of the lease on April 16, 2024. Our principal offices will represent 2 446,7 square meter facility. Our primary U.S office is located in Basking Ridge, New Jersey.
Added
The lease agreement for the previous corporate headquarters occupying 4,470 square meter facility in Montrouge, France, signed on March 3, 2015, which expired on May 31, 2024. Our primary U.S. office is located in Warren, New Jersey.
Added
In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. We also have facilities in North America that support our U.S. operations.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

6 edited+1 added−1 removed3 unchanged
Biggest changeRecent Sales of Unregistered Equity Securities During the year ended December 31, 2023, we issued the following unregistered securities: • On March 23, 2023, the issuance of an aggregate of 10,174 ordinary shares to U.S. and on-U.S. employees upon settlement of RSUs; • On May 29, 2023, the issuance of an aggregate of 2,500 ordinary shares to a non-U.S. employee upon settlement of RSUs; • On May 22, 2023, the issuance of an aggregate of 14,364 ordinary shares to non-U.S. employees upon settlement of RSUs; • On May 24, 2023, the issuance of an aggregate of 34,321 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • On September 23, 2023, the issuance of an aggregate of 2,599 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering.
Biggest changeRecent Sales of Unregistered Equity Securities During the year ended December 31, 2024, we issued the following unregistered securities: • on March 23, 2024, the issuance of an aggregate of 2,599 ordinary shares to U.S. and on-U.S. employees upon settlement of RSUs; • on May 12, 2024, the issuance of an aggregate of 1,600 ordinary shares to U.S. employees upon settlement of RSUs; • on May 19, 2024, the issuance of an aggregate of 2,500 ordinary shares to U.S. employees upon settlement of RSUs; • on May 22, 2024, the issuance of an aggregate of 22,112 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • on May 24, 2024, the issuance of an aggregate of 32,497 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • on July 29, 2024, the issuance of an aggregate of 5,849 ordinary shares to U.S. employees upon settlement of RSUs; • on September 23, 2024, the issuance of an aggregate of 2,599 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • on November 12, 2024, the issuance of an aggregate of 400 ordinary shares to U.S. employees upon settlement of RSUs; • on November 19, 2024, the issuance of an aggregate of 2,500 ordinary shares to non-U.S. employees upon settlement of RSUs; • on November 20, 2024, the issuance of an aggregate of 97,436 ordinary shares to non-U.S. employees upon settlement of RSUs; • on November 21, 2024, the issuance of an aggregate of 166,874 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; • on November 22, 2024, the issuance of an aggregate of 21,925 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and • on November 24, 2024, the issuance of an aggregate of 46,840 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering.
The sales of these securities were made without any general solicitation or advertising. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Item 6. [Reserved].
The sales of these securities were made without any general solicitation or advertising. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.
The number of beneficial owners of the ADSs in the United States is likely to be much larger than the number of record holders of our ordinary shares in the United States.
This number of holders of record also does not include holders whose shares may be held in trust by other entities. The number of beneficial owners of the ADSs in the United States is likely to be much larger than the number of record holders of our ordinary shares in the United States.
The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares or ADSs are held in street name by brokers and other nominees. This number of holders of record also does not include holders whose shares may be held in trust by other entities.
Holders of Ordinary Shares As of December 31, 2024, there were approximately 309 holders of record of our ordinary shares and 33 holders of record of our ADSs. The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares or ADSs are held in street name by brokers and other nominees.
Our ordinary shares have been trading on Euronext Paris under the symbol “DBV” since March 28, 2012.
Our ordinary shares have been trading on Euronext Paris under the symbol “DBV” since March 28, 2012. Prior to that date, there was no public trading market for our ADSs or our ordinary shares.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our ADSs have been listed on the Nasdaq Global Select Market under the symbol “DBVT” since October 22, 2014. Prior to that date, there was no public trading market for our ADSs.
Market Information Our ADSs were transferred from the Nasdaq Global Select Market to the Nasdaq Capital Market on June 18, 2024 under the symbol “DBVT.” Prior to that date, our ADSs were listed on the Nasdaq Global Select Market under the symbol “DBVT” since October 22, 2014. Prior to that date, there was no public trading market for our ADSs.
Removed
Prior to that date, there was no public trading market for our ADSs or our ordinary shares. 100 Holders of Ordinary Shares As of March 6, 2024, there were approximately 402 holders of record of our ordinary shares and 65 holders of record of our ADSs.
Added
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

61 edited+27 added−24 removed41 unchanged
Biggest changeOther operating income increased by $7.8 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022 mainly due the reversal of deferred revenue following the Mutual Termination Letter Agreement, effective October 30, 2023, of the Collaboration Agreement between the Company and Nestlé Health Science. 108 Operating Expenses Research and Development Expenses The following table summarizes our research and development expenses for the years presented: December 31, $ change % change (Dollar amounts presented in thousands) 2023 2022 Research and development expenses External clinical-related expenses 49,044 42,248 6,796 16 % Employee-related costs excl. share-based payment expenses 14,401 10,752 3,649 34 % Share-based payment expenses 2,496 2,303 193 8 % Depreciation and amortization (13,658 ) 12,965 (26,623 ) (205 %) Other costs 7,940 7,276 664 9 % Total Research and development expenses 60,223 75,443 (15,320 ) (20 %) Our research and development expenses consisted primarily of external costs, such as startup fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical trials, and costs related to acquiring and manufacturing clinical study materials.
Biggest changeOperating Expenses Research and Development Expenses The following table summarizes our research and development expenses for the years presented: December 31, 2024 2023 $ change % of change Research and Development expenses External clinical-related expenses 62,448 49,044 13,404 27 % Employee-related costs 17,213 14,401 2,812 20 % Share-based payment expenses 2,343 2,496 (153) (6) % Depreciation and amortization (719) (13,658) 12,939 (95) % Other costs 8,058 7,940 118 1 % Total Research and Development expenses 89,342 60,223 29,120 48 % Research and Development expenses increased by $29.1 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, mainly due to external clinical-related expenses increasing by $13.4 million from both an increase in participant enrollment in the VITESSE Phase 3 clinical trial and the preparatory activities for the COMFORT studies.
Research and development expense consists primarily of: • cost of third-party contractors such as contract research organizations, or CROs, that conduct our non- clinical studies and clinical trials; • personnel costs, including salaries, related benefits and share-based compensation, for our employees engaged in scientific research and development functions; 103 • purchases, real-estate leasing costs, as well as conferences and travel costs; and • depreciation, amortization and provisions.
Research and development expense consists primarily of: • cost of third-party contractors such as contract research organizations, or CROs, that conduct our non-clinical studies and clinical trials; • personnel costs, including salaries, related benefits and share-based compensation, for our employees engaged in scientific research and development functions; • purchases, real-estate leasing costs, as well as conferences and travel costs; and • depreciation, amortization and provisions.
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due any 111 future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises.
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises.
The expenditures taken into account for the calculation of the research tax credit involve only research expenses. 105 If a company meets certain criteria in terms of sales, headcount or assets to be considered a Small and Medium- sized Enterprises, or SMEs, under EU law, immediate payment of the CIR can be requested.
The expenditures taken into account for the calculation of the research tax credit involve only research expenses. If a company meets certain criteria in terms of sales, headcount or assets to be considered a Small and Medium-sized Enterprises, or SMEs, under EU law, immediate payment of the CIR can be requested.
In addition, the 2022 Warrants do not provide any guarantee of value or return. 115 Accordingly, the pre-funded warrants are classified as equity and accounted for as a component of additional paid-in capital at the time of issuance. Smaller Reporting Company Status We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended.
In addition, the 2022 Warrants do not provide any guarantee of value or return. Accordingly, the pre-funded warrants are classified as equity and accounted for as a component of additional paid-in capital at the time of issuance. Smaller Reporting Company Status We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended.
Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including statements of our plans, objectives, expectations and 101 intentions, contain forward-looking statements that involve risks and uncertainties.
Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including statements of our plans, objectives, expectations and intentions, contain forward-looking statements that involve risks and uncertainties.
The Company was eligible to receive up to €100.0 millions ($105.0 millions at December 31, 2023 closing exchange rate) in potential development, clinical, regulatory and commercial milestones, including an upfront payment of €10.0 millions received in July 2016. On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement.
The Company was eligible to receive up to €100.0 million ($105.0 million at December 31, 2023 closing exchange rate) in potential development, clinical, regulatory and commercial milestones, including an upfront payment of €10.0 million received in July 2016. On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement.
GAAP are based on complex and subjective 113 assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the facts and circumstances concerned.
GAAP are based on complex and subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the facts and circumstances concerned.
Our therapeutic approach is based on epicutaneous immunotherapy, or EPITTM, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated.
Our therapeutic approach is based on epicutaneous immunotherapy, or EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated.
Financial Overview Since our inception, we have primarily funded our operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche).
Financial Overview Since our inception, we have primarily funded our operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credit (crédit d’impôt recherche).
Consequently, as of the signing of the Mutual Termination Letter Agreement and as of December 31 2023, we recorded the following : • Loss on completion accrual reversal $19,9 millions; • Deferred revenue accrual reversal $6.9 millions; • Accrual for ongoing Clinical study completion $2.3 millions.
Consequently, as of the signing of the Mutual Termination Letter Agreement and as of December 31, 2023, we recorded the following: • Loss on completion accrual reversal $19,9 million; • Deferred revenue accrual reversal $6.9 million; • Accrual for ongoing Clinical study completion of $2.3 million as of December 31, 2023.
Components of Our Results of Operations Operating Income Our operating income consists of other operating income, as described below, as we generated no revenue from our operating activities in 2023 or 2022.
Components of Our Results of Operations Operating Income Our operating income consists of other operating income, as described below, as we generated no revenue from our operating activities in 2024 or 2023.
We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
We imay needadditional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
Finance Income (Expense) Our cash and cash equivalents have been deposited primarily in savings and deposit accounts with a short term remaining maturity at the date of purchase or less, refundable within one month, for which the risk of changes in value is considered to be insignificant.
Finance Income (Expense) Our cash and cash equivalents have been deposited primarily in savings and deposit accounts with a short term remaining maturity at the date of purchase or less, refundable within 32 days or less, for which the risk of changes in value is considered to be insignificant.
Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.76 and $1.24 for the year ended December 31, 2023 and 2022, respectively.
Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.17 and $0.76 for the year ended December 31, 2024 and 2023, respectively.
We expect that our Research and Development expenses will continue to increase in the foreseeable future as we initiate clinical trials for certain product candidates and pursue later stages of clinical development of our product candidates. In the year ended December 31, 2023, we spent $60.2 million in research and development expenses to advance the development of our product candidates.
We expect that our Research and Development expenses will continue to increase in the foreseeable future as we initiate clinical trials for certain product candidates and pursue later stages of clinical development of our product candidates. In the year ended December 31, 2024, we spent $89.3 million in Research and Development expenses to advance the development of our product candidates.
In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 5,799 square feet in Basking Ridge, New Jersey. The Basking Ridge office represent a $0.4 million cash requirement as of December 31, 2022 which expires June 1, 2025.
In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 579 square feet. The Basking Ridge office represent a $0.1 million cash requirement as of December 31, 2024 which expires June 1, 2025.
Consultants, costs of clinical trials 106 costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other external costs, depreciation (of Research and Development equipments and other depreciation related to Research and Development like loss on completion on MAG1C study), and facility costs related to the development of drug candidates.
Consultants, costs of clinical trials costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other external costs, depreciation (of Research and Development equipment and other costs related to Research and Development like loss on completion on MAG1C study until December 31, 2023), and facility costs related to the development of drug candidates.
Consequently, since signing the Mutual Termination Letter Agreement and as of December 31 , 2023, we recorded the following : • Loss on completion accrual reversal $19,9 millions (Other Operating Income); • Deferred revenue accrual reversal $6.9 millions (Operating Expenses); • Accrual for ongoing Clinical study completion $2.3 millions (Operating Expenses).
Consequently, since signing the Mutual Termination Letter Agreement and as of December 31, 2023, we had recorded the following: • Loss on completion accrual reversal of $19.9 million (Other Operating Income); • Deferred revenue accrual reversal of $6.9 million (Operating Expenses); • An Accrual of $2.3 million for the remaining expenses related to the ongoing clinical study fully expensed in 2024.
We expect to continue this investment strategy. 107 Results of Operations Comparison of the Years Ended December 31, 2023 and 2022 The following table summarizes the results of our operations, derived from our consolidated financial statements, prepared in compliance with generally accepted accounting principles in the United States, or U.S.
Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes the results of our operations, derived from our consolidated financial statements, prepared in compliance with generally accepted accounting principles in the United States, or U.S.
As of December 31, 2023, expenses associated with the ongoing trials amounted globally to $114.4 million, and we had non-cancellable contractual obligations with CRO until year ended 2025 amounting to $44.2 million. Cash flows The table below summarizes our sources and uses of cash for the years ended December 31, 2023 and 2022.
As of December 31, 2024, expenses associated with the ongoing trials amounted globally to $170.3 million, and we had non-cancellable contractual obligations with CRO until the year ended 2026 amounting to $10.0 million. Cash flows The table below summarizes our sources and uses of cash for the years ended December 31, 2024 and 2023.
Liquidity and Capital Resources Financial Condition On December 31, 2023, we held $141.4 millions in cash and cash equivalents compared to $209.2 millions of cash and cash equivalents on December 31, 2022.. Net cash used for operating activities was $79.6 and 110 $55.7 million for the years ended December 31, 2023 and 2022, respectively.
Liquidity and Capital Resources Financial Condition On December 31, 2024, we held $32.5 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023. Net cash used for operating activities was $104.5 million and $79.7 million for the years ended December 31, 2024 and 2023, respectively.
The table does not include obligations under agreements that we can cancel without a significant penalty. Future events could cause actual payments to differ from these estimates. Operating leases Our corporate headquarters are located in Montrouge, France.
The table does not include obligations under agreements that we can cancel without a significant penalty. Future events could cause actual payments to differ from these estimates.
We estimated the following assumptions for the calculation of the fair value of our stock options: Assumptions per year ended December 31, Stock options per grant date 2023 2022 Weighted average shares price at grant date in € 2,08 2,33 Weighted average expected volatility 97,02 % 98,90 % Weighted average risk-free interest rate 2,99 % 2,20 % Weighted average expected term (in years) 6 6 Dividend yield — — Weighted average fair value of stock-options in € 1,33 2,23 * The weighted average fair value of underlying shares is presented in euros, as we are incorporated in France and the euro is the currency used for the grants.
We estimated the following assumptions for the calculation of the fair value of our stock options: Assumptions per year ended December 31, Stock options per grant date 2024 2023 Weighted average shares price at grant date in € 0.76 2.03 Weighted average expected volatility 90.61% 93.70% Weighted average risk-free interest rate 2.58% 2.95% Weighted average expected term (in years) 6.25 6 Dividend yield — — Weighted average fair value of stock-options in €* 0.57 1.67 * The weighted average fair value of underlying shares is presented in euros, as we are incorporated in France and the euro is the currency used for the grants.
Expected volatility We determine the expected volatility based on the historical data period corresponding to the stock options expected maturity. Expected dividend yield We have never declared or paid any cash dividends and we do not presently plan to pay cash dividends in the foreseeable future. Consequently, we use an expected dividend yield of zero.
Expected dividend yield We have never declared or paid any cash dividends and we do not presently plan to pay cash dividends in the foreseeable future. Consequently, we use an expected dividend yield of zero.
Certain Research and Development projects are, or have been, partially funded by collaboration agreements, The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred.
The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred.
Savings and deposit accounts generate a limited amount of interest income, with very low counterparty risks.
Savings and deposit accounts generate a limited amount of interest income, with very low counterparty risks. We expect to continue this investment strategy.
The Company records upfront, non-refundable payments made to outside vendors, or other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered.
The Company records upfront, non-refundable payments made to outside vendors, or other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered. Certain Research and Development projects are, or have been, partially funded by collaboration agreements.
In November, 2023, the Company entered into new agreements to relocate its headquarters in Chatillon, France: • a short term lease agreement for the fitting works of the new offices, • a lease agreement starting April 16, 2024 with a minimum duration of six years. Our primary U.S. office is located in Basking Ridge, New Jersey.
Operating leases In November 2023, the Company entered into new agreements to relocate its headquarters in Châtillon, France: • a short term lease agreement for the fitting works of the new offices, • a lease agreement starting April 16, 2024 with a minimum duration of six years.
The COVID-19 pandemic and the conflict in Ukraine caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
We do not generate product revenue and continue to prepare for the potential launch of our first product in the United States and in the European Union, if approved.
We do not generate product revenue and continue to prepare for the potential launch of our first product in the United States and in the European Union, if approved. The Company has incurred operating losses and negative cash flows from operations since inception.
We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
(2) If we exclude Mag1c impact the percentage of research and development expenses related to Viaskin Peanut in 2023 would be 84% (3) If we exclude Mag1c impact the percentage of research and development expenses related to Viaskin Milk in 2023 would be 8% We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when, or to what extent we will generate revenue from the commercialization and 104 sale of any of our product candidates that obtain regulatory approval.
We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when, or to what extent we will generate revenue from the commercialization and sale of any of our product candidates that obtain regulatory approval.
In light of the current stage of regulatory interactions regarding Viaskin Peanut, we achieved the resizing of our facility use in North America that was initially intended to support our U.S. subsidiary as well as future commercialization needs, explaining partially operating leases costs as of December 31, 2023 and December 31, 2022 : • In January 2022, we concluded a termination agreement for our 21,548 square feet commercial facility in Summit, New Jersey.
In light of the current stage of regulatory interactions regarding Viaskin Peanut, we achieved the resizing of our facility use in North America to support our U.S. subsidiary as well as future commercialization needs, explaining partially operating leases costs as of December 31, 2024 and December 31, 2023: • Our primary U.S. office is located in Warren, New Jersey.
Determining the fair value of the share-based payments at the grant date requires judgment. We calculated the fair value of stock options on the grant date using the Black-Scholes option pricing model.
Determining the fair value of the share-based payments at the grant date requires judgment. We calculated the fair value of stock options on the grant date using the Black-Scholes option pricing model. The Black-Scholes model requires the input of highly subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield.
Critical Accounting Policies and Significant Judgments and Estimates Our financial statements are prepared in accordance with U.S. GAAP. Some of the accounting methods and policies used in preparing our financial statements under U.S.
The liquidity agreement has a term of one year and will renew automatically unless otherwise terminated by either party. Critical Accounting Policies and Significant Judgments and Estimates Our financial statements are prepared in accordance with U.S. GAAP. Some of the accounting methods and policies used in preparing our financial statements under U.S.
Income tax Our income tax expense was $7,000 for the year ended December 31, 2023, compared to a US Tax income of $70,000 for the year ended December 31, 2022. Net loss Net loss was $72.7 million for the year ended December 31, 2023, compared to $96.3 million for the year ended December 31, 2022.
Income tax Our income tax expense was $55 thousand for the year ended December 31, 2024, compared to an income tax expense of $7 thousand for the year ended December 31, 2023. Net loss Net loss was $113.9 million for the year ended December 31, 2024, compared to $72.7 million for the year ended December 31, 2023.
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets resulting from geopolitical instability, macroeconomic conditions, global health crises, or other factors. 102 If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
The following table presents our material expenses commitments for future periods: Material expenses Commitments Due by the Year Ended December 31, 2024 2025 2026 Thereafter Total (Amounts in thousands) Operating leases 1,205 65 421 5,514 7,205 Purchase obligations—Obligations Under the Terms of CRO commitments 22,732 11,006 1,406 1,831 36,974 Total 23,937 11,071 1,827 7,345 44,179 The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts.
The following table presents our material expenses commitments for future periods: Material Cash Requirements Due by the Year Ended December 31, 2025 2026 2027 Thereafter Total (Amounts in thousands) Operating leases 836 1,228 1,237 5,136 8,437 Purchase obligations - Obligations Under the Terms of CRO Agreements 8,439 1,541 502 48 10,530 Total 9,275 2,769 1,739 5,184 18,967 The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts.
During the years ended December 31, 2023 and 2022, we obtained the following financing on the public markets by issuance of securities, net of commissions and estimated offering expenses: Equity capital Bank Loans Other debt Total (Amounts in thousands of U.S.
During the years ended December 31, 2023 and 2022, we obtained the following financing on the public markets by issuance of securities, net of commissions and estimated offering expenses: Equity capital Bank loan Other debt Total 2022 194,446 — — 194,446 2023 6,921 — — 6,921 Total 201,367 — — 201,367 We have incurred net losses each year since our inception.
Beginning in the fiscal year ending December 31, 2021, we recovered our SME status, and became therefore eligible again for the immediate reimbursement of the CIR. During the fiscal year ending December 31, 2022, the Company received the reimbursement of the 2019, 2020 and 2021 fiscal year research tax credits for a total amount of $26.1 million.
After two consecutive years in 2019 and 2020 without the SME status, we recovered our SME status, beginning in the fiscal year ending December 31, 2021, and became therefore eligible again for the immediate reimbursement of the CIR.
During the fiscal year ending December 31, 2023, the Company received the reimbursement of the 2022 fiscal year research tax credits for a total amount of $5.9 million. Collaboration Agreement with Nestlé Health Science In May 2016, we entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”).
Collaboration Agreement with Nestlé Health Science In May 2016, we entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”).
In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached.
In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company.
Risk-free interest rate The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the maturity of the share options. Expected term We determine the expected term based on the average period the stock options are expected to remain outstanding.
Exercise price The exercise price of our stock options is based on the fair market value of our ordinary shares. Risk-free interest rate The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the maturity of the share options.
Consistent with customary practice in the French securities market, we entered into a liquidity agreement ( contrat de liquidité ) with Natixis on April 13, 2012. The liquidity agreement complies with applicable laws and regulations in France. The liquidity agreement authorizes Natixis to carry out market purchases and sales of our shares on Euronext Paris.
Financing Activities Our net cash flows resulting from financing activities were $0.6 million in 2024 and $6.8 million in 2023 from the ATM. Consistent with customary practice in the French securities market, we entered into a liquidity agreement ( contrat de liquidité ) with Natixis on April 13, 2012. The liquidity agreement complies with applicable laws and regulations in France.
Research and Development Expenses Research and Development expenses comprise clinical trials direct costs as well as salaries, share-based payments and benefits for internal Research and Development personnel.
Operating Expenses Since our inception, our operating expenses have consisted primarily of Research and Development activities, General and Administration costs and to lesser extent sales and marketing costs. Research and Development Expenses Research and Development expenses comprise clinical trials direct costs as well as salaries, share-based payments and benefits for internal Research and Development personnel.
The workforce dedicated to general and administrative activities increased from 27 employees in 2022 to 34 employees in 2023. Financial income (loss) Our financial income was $3.7 millions in 2023 and $0.4 million in 2022, and primarily includes the financial income on our financial assets and foreign exchange gains.
Financial income (loss) Our financial income was $2.7 million in 2024 and $3.7 million in 2023, and primarily includes the financial income on our financial assets and foreign exchange gains.
Dollars) Research and development expenses related to Viaskin Peanut (1) $ 60,329 $ 47,766 As a percentage of research and development expenses, excluding share-based compensation Expense (2) 105 % 65 % Research and development expenses related to Viaskin Milk (1) $ 6,019 $ 8,180 As a percentage of research and development expenses excluding share-based compensation Expense (3) 10 % 11 % Other research and development expenses (1) $ (8,621 ) $ 17,295 Total research and development expenses, excluding share-based compensation expense $ 57,727 $ 73,241 Share-based compensation expenses included in research and development expenses $ 2,496 $ 2,303 Total research and development expenses $ 60,223 $ 75,543 (1) Excludes employee share-based compensation expense after $19,9 millions loss on completion accrual reversal as of December 2023.
The following table provides a breakdown of our direct Research and Development expenses for our two lead development programs, as well as expenses not allocated to the programs and share-based compensation expenses included in Research and Development expenses, for the years ended December 31, 2024 and 2023, respectively: December 31, 2024 2023 Viaskin Peanut(1) 80,479 60,329 As a percentage of research and development expenses, excluding share- 93 % 105 % based compensation Expense(2) Research and development expenses related to Viaskin Milk(1) 3,638 6,019 As a percentage of research and development expenses excluding share-based compensation Expense(3) 4 % 10 % Other research and development expenses(1) 2,881 (8,621) Total research and development expenses, excluding share-based compensation expense 86,999 57,727 Share-based compensation expenses included in research and development expenses 2,343 2,496 Total research and development expenses 89,343 60,223 (1) Excludes employee share-based compensation expense after $19.9 million loss on completion accrual reversal as of December 2023.
This accrual represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2023 and until the end of the study. Clinical studies costs committed beyond December 31 2023 are to be settled by DBV.
This updated accrual of $22 thousand represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2024 and until the end of the study. Share-Based Compensation We have several share-based compensation plans for employees and non-employees.
Sales and Marketing Expenses The following table summarizes our sales and marketing expenses for the years presented: December 31, $ change % change (Dollar amounts presented in thousands) 2023 2022 Sales and marketing expenses Employee-related costs incl. share-based payment expenses 754 914 (160 ) (18 %) External professional services and other costs 1,784 694 990 143 % Total Sales and marketing expenses 2,438 1,608 830 52 % Sales and marketing expenses primarily included payroll for the U.S. and European employees as well as fees related to pre- commercialization activities for Viaskin Peanut in North America.
Sales and Marketing Expenses The following table summarizes our sales and marketing expenses for the years presented: December 31, 2024 2023 $ change % of change Sales & Marketing expenses External professional services and other costs 1,770 1,684 86 5 % Employee-related costs incl. share-based payment expenses 890 754 136 18 % Total Sales & Marketing expenses 2,659 2,438 222 9 % Sales and marketing expenses increased by $0.2 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America.
The increase in operating income is due to the increase in research tax credit and the revenue recognition of $6.9 millions related to the deferred revenue following the termination of the Collaboration Agreement with Nestlé.
The decrease in operating income is due to a lower Research Tax Credit. and nil revenue recognition from January 1, 2024 onward due to the termination of the Collaboration Agreement with NESTEC.
A corrective Research tax credit was filed by the Company for $2.9 millions for 2020, 2021 and 2022 fiscal year research tax credit during the year ended December 31, 2023.
During the fiscal year ended December 31, 2023, the Company received the reimbursement of the 2022 fiscal year research tax credit for a total amount of $5.9 million.
Dollars) 2022 194,446 — — 194,446 2023 6,921 — — 6,921 Total 201,367 — — 201,367 We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.
Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt. We may seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.
General and Administrative Expenses The following table summarizes our general and administrative expenses for the years presented: December 31, $ change % change (Dollar amounts presented in thousands) 2023 2022 General and administrative expenses External professional services fees 8,750 5,947 2,803 47 % Employee-related costs excl. share-based payment expenses 8,200 7,320 881 12 % Share-based payment expenses 3,389 2,688 701 26 % Depreciation, amortization and other costs 9,161 8,369 2,523 30 % Total General and administrative expenses 29,500 24,324 5,176 21 % General and administrative expenses increased by $5.2 millions for the year ended December 31, 2023, compared to the year ended December 31, 2022.
General and Administrative Expenses The following table summarizes our general and administrative expenses for the years presented: December 31, 2024 2023 $ change % of change General & Administrative expenses External professional services 10,052 8,750 1,302 15 % Employee-related costs 8,981 8,201 780 10 % Share-based payment expenses 2,161 3,388 (1,227) (36) % Depreciation, amortization and other costs 7,545 9,161 (1,617) (18) % Total General & Administrative expenses 28,739 29,500 (762) (3) % General and administrative expenses decreased by $(0.8) million for the year ended December 31, 2024, compared to the year ended December 31, 2023.
GAAP, for the years ended December 31, 2023 and 2022: December 31, $ change % change (Dollar amounts presented in thousands, except per share amounts) 2023 2022 Operating income $ 15,728 $ 4,844 10,885 225 % Operating expenses Research and development expenses (60,223 ) (75,543 ) 15,320 (20 %) Sales and marketing expenses (2,438 ) (1,608 ) (830 ) 52 % General and administrative expenses (29,500 ) (24,324 ) (5,176 ) 21 % Restructuring income (expenses) — — — — Total Operating expenses (92,161 ) (101,475 ) 9,314 (9 %) Financial income (expense) 3,714 427 3,286 769 % Income tax (7 ) (70 ) 63 (90 %) Net loss $ (72,726 ) $ (96,274 ) 23,548 (24 %) Basic/diluted Net loss per share attributable to shareholders (0.76 ) (1.24 ) Operating Income The following table summarizes our operating income for the years presented: December 31, $ change % change (Dollar amounts presented in thousands) 2023 2022 Sales — — Other income 15,728 4,844 10,884 225 % Research tax credit 8,766 5,718 3,048 53 % Other operating (loss) income 6,962 (874 ) 7,836 (896 %) Total operating income 15,728 4,844 10,884 225 % We generated operating income of $15.7 millions for the year ended December 31, 2023 compared to $4.8 millions for the year ended December 31, 2022.
GAAP, for the years ended December 31, 2024 and 2023: December 31, 2024 2023 $ change % of change Operating income 4,151 15,728 (11,577) (74) % Operating expenses Research and development expenses (89,342) (60,223) (29,119) 48 % Sales and marketing expenses (2,659) (2,438) (222) 9 % General and administrative expenses (28,739) (29,500) 762 (3) % Total Operating expenses (120,740) (92,161) (28,579) 31 % Loss from operations (116,589) (76,432) (40,157) 53 % Financial income (expense) 2,726 3,714 (987) (27) % Loss before taxes (113,863) (72,719) (41,144) 57 % Income tax (55) (7) (49) 721 % Net loss (113,918) (72,726) (41,192) 57 % Basic/diluted Net loss per share attributable to shareholders (1.17) (0.76) — — Operating Income The following table summarizes our operating income for the years presented: December 31, 2024 2023 $ change % of change Sales — — — — Other income 4,151 15,728 (11,577) (74) % Research tax credit 4,146 8,766 (4,620) (53) % Other operating income 5 6,962 (6,957) (100) % Total operating income 4,151 15,728 (11,577) (74) % We generated operating income of $4.2 million for the year ended December 31, 2024 compared to $15.7 million for the year ended December 31, 2023.
The amount is classified in other non-current financial assets in our statement of financial position. At December 31, 2023, 222,988 shares and $0.2 million were in the liquidity account. The liquidity agreement has a term of one year and will renew automatically unless otherwise terminated by either party.
The liquidity agreement authorizes Natixis to carry out market purchases and sales of our shares on Euronext Paris. The amount is classified in other non-current financial assets in our statement of financial position. At December 31, 2024, 266,868 shares and $0.1 million were in the liquidity account.
Sales and Marketing expenses increased by $0.8 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, primarily due to an increase in fees related to pre-commercialization activities for Viaskin Peanut in North America. 109 Employee-related costs (including share-based payments expenses) related to payroll for the U.S. and European employees, decreased by $0.2 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, due to employee departure in the US.
Employee-related costs, excluding share-based payments, increased by $2.8 million for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to the recruitment of 12 full-time employees (“FTE”) in Medical, Quality and Regulatory Affairs, mostly based in the U.S.
External professional services and other costs increased by $1.0 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, mainly due to an increase in fees related to pre-commercialization activities for Viaskin Peanut in North America.
External professional services increased by $1.3 million for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to one-time costs associated with (1) office moves in France and the U.S, (2) financing activities and (3) trademark and patent activities.
Dollars) 2023 2022 Net cash flows used in operating activities (79,653 ) (55,666 ) (23,982 ) 43 % Net cash flows used in investing activities (808 ) (100 ) (1,017 ) 1016 % Net cash flows provided by financing activities 6,767 194,120 (187,045 ) (96 %) Effect of exchange rate changes on cash and cash equivalents 5,867 (6,461 ) 12,328 (191 %) Net (decrease) increase in cash and cash equivalents (67,827 ) 131,893 (199,716 ) * * Percentage not meaningful Operating Activities Our net cash flows used in operating activities were $79.7 millions and $55.7 millions in 2023 and 2022 respectively.
Dollars) 2024 2023 $ change % of change Net cash flow used in operating activities (104,474) (79,653) (24,821) 31 % Net cash flow used in investing activities (757.0) (808.3) 51.304 (6) % Net cash flow provided by financing activities 587 6,767 (6,180) (91) % Effect of exchange rate changes on cash and cash equivalents (4,268) 5,867 (10,135) (173) % Net (decrease) increase in cash and cash equivalents (108,913) (67,827) (41,085) 61 % Operating Activities Our net cash flows used in operating activities were $104.5 million and $79.7 million in 2024 and 2023 respectively.
Research and Development expenses decreased by $15.3 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022 mainly as a result of : • loss on completion accrual net reversal $17,6 millions (compared to a $10.4 millions depreciation as of December 31, 2022) resulting from Nestlé Collaboration Agreement termination, that offset; • the global increase of $11.3 million in research and development expenses.
Depreciation, amortization and other costs increased by $12.9 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, mainly due to (1) the termination of the Collaboration Agreement with NESTEC that explained the accrual net reversal in 2023, (2) accruals reversals on CRO activities, and (3) Medical, Quality and Regulatory Affairs activities.
Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 3, 2015 and represents a $1.1 million cash requirement as of December 31, 2023 until July, 2024.
Our corporate headquarters represents a $6.3 million cash requirement as of December 31, 2024 until April 2033.
Removed
Based on its current operations, the Company expects that its balance of cash and cash equivalents of $141.4 million as of December 31, 2023 will be sufficient to fund its operations until December 31, 2024. The company has incurred operating losses and negative cash flows from operations since inception.
Added
Subsequent to December 31, 2024, the Company raised additional proceeds in a private placement financing (the “2025 PIPE”) consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7 2025 for an amount of €38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares").
Removed
As of the date of the filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern.
Added
The Company received initial net proceeds of $125.5 million (€116.3 million) on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026.
Removed
We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings before December 31, 2024.
Added
We further estimate that, following the potential issuance of all Warrant Shares in the financing, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), we could extend our financial visibility into 2028 and through potential commercialization of Viaskin Peanut in the U.S, if approved.
Removed
Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives.
Added
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets resulting from geopolitical instability, macroeconomic conditions, global health crises, or other factors.
Removed
As such, no adjustments have been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern. Business Trends We engage in substantial research and development efforts to develop innovative pharmaceutical product candidates.
Added
Our Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operations since inception.
Removed
The following table provides a breakdown of our direct research and development expenses for our two lead development programs, as well as expenses not allocated to the programs and share-based compensation expenses included in research and development expenses, for the years ended December 31, 2023 and 2022, respectively: Year Ended December 31, 2023 2022 (thousands of U.S.
Added
The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and research tax credit.
Removed
We no longer benefited from the immediate reimbursement of the CIR due to the loss of the SME status under EU law for the fiscal year ending December 31, 2019 and 2020. The CIRs were to be refunded three years after the tax declaration in the event we could not offset it against corporate income tax due.
Added
Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union. In 2022, the Company secured a private placement financing of $194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study.
Removed
This accrual represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2023 and until the end of the study. Operating Expenses Since our inception, our operating expenses have consisted primarily of Research and Development activities, General and Administration costs and to lesser extent sales and marketing costs.
Added
On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 20.
Removed
Research tax credit increased by $3.0 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022 as a result of the extension of the eligible expense base to include clinical supplies.
Added
With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.
Removed
External clinical-related expenses increased by $6.8 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022, reflecting intensified Research and Development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers and children after the FDA confirmed additional safety data is required for BLA.

… 32 more changes not shown on this page.

Other DBVT 10-K year-over-year comparisons