ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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177-181 avenue Pierre Brossolette |
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Large accelerated filer |
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Emerging growth company |
• | the impact of the ongoing COVID-19 pandemic, including the emergence of new variant strains of COVID-19, and its effects on our operations, research and development, clinical trials and ability to obtain financing and potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers and collaborators with whom we conduct business; |
• | our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission of a Biologics License Application, or a BLA, for ViaskinTM Peanut to the U.S. Food and Drug Administration, or the FDA; |
• | the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; |
• | the sufficiency of existing capital resources; |
• | our business model and our other strategic plans for our business, product candidates and technology; |
• | our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates; |
• | our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved; |
• | the commercialization of our product candidates, if approved; |
• | our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets; |
• | the pricing and reimbursement of our product candidates, if approved; |
• | the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community; |
• | our ability to advance product candidates into, and successfully complete, clinical trials; |
• | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
• | estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
• | the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; |
• | our ability to maintain and establish collaborations or obtain additional grant funding; |
• | our financial performance; |
• | developments relating to our competitors and our industry, including competing therapies; and |
• | other risks and uncertainties, including those listed under the caption “Risk Factors.” |
• | We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. These factors raise substantial doubt regarding our ability to continue as a going concern. |
• | We will require substantial additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit, or terminate our product development efforts or other operations. |
• | We are limited in our ability to raise additional share capital, which may make it difficult for us to raise capital to fund our operations. |
• | COVID-19 may materially and adversely affect our business and our financial results. |
• | We are obligated to develop and maintain a system of effective internal controls over financial reporting. These internal controls may be determined to be not effective, which may adversely affect investor confidence in our company and, as a result, the value of our ordinary shares and ADSs. |
• | We depend almost entirely on the successful development of our novel Viaskin technology. We cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, Viaskin products. |
• | Our product candidates have undergone and/or will be required to undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure. If clinical trials of our product candidates fail to satisfactorily demonstrate safety and efficacy to the FDA and other regulators, we, or our collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates. |
• | In our clinical trials, we utilize an oral food challenge procedure intentionally designed to trigger an allergic reaction, which could be severe or life-threatening. |
• | Delays, suspensions and terminations in our clinical trials could result in increased costs to us and delay or prevent our ability to generate revenues. |
• | If our product candidates are not approved by the FDA, we will be unable to commercialize them in the United States. |
• | The approval process outside the United States varies among countries and may limit our ability to develop, manufacture and sell our products internationally. Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad. |
• | Even if we, or our collaborators, obtain marketing approvals for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we or they market our products, which could materially impair our ability to generate revenue. |
• | Any of our product candidates for which we, or our collaborators, obtain marketing approval in the future could be subject to postmarketing restrictions or withdrawal from the market and we, and our collaborators, may be subject to substantial penalties if we, or they, fail to comply with regulatory requirements or if we, or they, experience unanticipated problems with our products following approval. |
• | If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed, and our business will be harmed. |
• | Access to raw materials and products necessary for the conduct of clinical trials, for commercialization, if approved, and manufacturing of our product candidates and product, if any, is not guaranteed. |
• | Relying on third-party manufacturers may result in delays in our clinical development or commercialization efforts. |
• | We rely, and will rely in the future, on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays that prevent us from successfully commercializing product candidates. |
• | Even if collaborators with which we contract in the future successfully complete clinical trials of our product candidates, those candidates may not be commercialized successfully for other reasons. |
• | Currently, we do not have commercial-ready marketing and sales infrastructure. If we are unable to establish effective sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to effectively sell or market our product candidates, if approved, or generate product revenues. |
• | Our product candidates are regulated as biological products, or biologics, which may subject them to competition sooner than anticipated. |
• | Our product candidates may cause undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any. |
• | Changes in regulatory requirements, FDA guidance or guidance from certain European regulatory authorities or unanticipated events during our clinical trials of Viaskin patch products may occur, which may result in changes to clinical trial protocols or additional clinical trial requirements, which could result in increased costs to us and could delay our development timeline. |
• | If we do not secure collaborations with strategic partners to test, commercialize and manufacture certain product candidates outside of food allergies, we may not be able to successfully develop products and generate meaningful revenues. |
• | Our ability to compete may decline if we do not adequately protect our proprietary rights. |
• | Biopharmaceutical patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position. |
• | We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection. |
• | Failure or perceived failure to comply with existing or future laws, regulations, contracts, self-regulatory schemes, standards, and other obligations related to data privacy and security (including security incidents) could harm our business. Compliance or the actual or perceived failure to comply with such obligations could negatively affect our operating results and business. |
• | Our failure to maintain certain tax benefits applicable to French technology companies may adversely affect our results of operations. |
• | We may be forced to repay conditional advances prematurely if we fail to comply with our contractual obligations under the applicable innovation grant agreements. |
• | 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. |
• | If we are not able to comply with the applicable continued listing requirements or standards of the Nasdaq Global Select Market, or Nasdaq, our ADSs could be delisted. |
• | The dual listing of our ordinary shares and our ADSs may adversely affect the liquidity and value of the ADSs. |
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Item 1. |
Business. |
• | Pursue the continued development of Viaskin Peanut for toddlers and children with peanut allergy. |
• | Seek marketing approval for Viaskin Peanut in the United States and the European Union |
• | Advance the clinical development of additional Viaskin product candidates in the United States and other major markets. |
• | Build a broad immunotherapy product pipeline with our innovative Viaskin technology platform. |
• | 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. Due to this condensation chamber, the epidermis becomes more permeable allowing passage of the allergen into the epidermis. |
• | Once in the epidermis, the allergen is captured by a population of highly specialized cells: Langerhans cells. These cells can take the protein at the surface of the skin, process it and present its epitopes to the lymphocytes in the lymph nodes. |
• | PEPITES ( P eanut EPIT E fficacy and S afety Study) |
• | REALISE (REAL Life Use and Safety of EPIT), |
• | PEOPLE ( P EPITES OP en L abel E xtension S tudy) |
1. | Identify a modified Viaskin patch (which we call mVP). |
2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which we expected to be the longest component of the mVP clinical plan. We prioritized the STAMP protocol submission so we could begin the clinical trial as soon as possible. |
3. | Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established |
clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, we outlined our proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional Phase I clinical trials in healthy adult volunteers: |
a. | PREQUAL, a Phase I trial with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL. The data collection phase of the trial is complete, and the data analysis phase is ongoing. |
b. | ‘EQUAL in adults,’ a second Phase I trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP. |
• | A constant flow of liquid in a capillary is subjected to a high voltage electric field. |
• | With our electrospray machine, we can transform these electrically charged liquid droplets into dry solid layers, deposited onto the patch’s backing. |
• | The electric field directs particles precisely toward the Viaskin patch’s backing. |
• | a homogeneous layer of protein on the Viaskin patch; |
• | a specific mass of active substance per Viaskin patch; |
• | an adjustable active substance dosage and size for clinical trials; |
• | instant drying of the active substance; |
• | a high solubility of the active substance; and |
• | the possibility of spraying on the Viaskin patch both biological and chemical substances. |
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ES GEN3.1 (2009) 10 or 18 nozzles Used for Phase I and Phase II trials | |
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ES GEN3.2 (2014) 54 nozzles Used for Phase III trials Improved electrospray process, forerunner of ES GEN4.0 | |
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ES GEN4.0 (2017 & 2020) 288 nozzles To be used for clinical batches and commercial products Scalable to produce more patches annually |
• | patents and patent applications we co-own with AP-HP and the Université de Paris-Descartes relating to the Viaskin electrostatic patch and its use, half of which may expire as early as 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 de Paris-Descartes relating to the treatment of peanut allergies using our Viaskin patch technology, which may expire as early as 2028; 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. |
• | completion of extensive nonclinical, sometimes referred to as pre-clinical laboratory tests, pre-clinical animal studies and formulation studies in accordance with applicable regulations, including the FDA’s Good Laboratory Practice, or GLP, regulations; |
• | submission to the FDA of an IND, which must become effective before human clinical trials may begin; |
• | performance of adequate and well-controlled human clinical trials in accordance with applicable IND and other clinical trial-related regulations, sometimes referred to as good clinical practices, or GCPs, to establish the safety and efficacy of the proposed product candidate for its proposed indication; |
• | submission to the FDA of a BLA; |
• | satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the product is produced to assess compliance with the FDA’s current good manufacturing practice, or cGMP, requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, purity and potency; |
• | potential FDA audit of the pre-clinical and/or clinical trial sites that generated the data in support of the BLA; and |
• | FDA review and approval of the BLA prior to any commercial marketing or sale of the product in the United States. |
• | 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. Our Viaskin product candidates are combination products comprising a device for delivery of a biologic. Under the FDCA, the FDA is charged with assigning a center with primary jurisdiction, or a lead center, for review of a combination product. That determination is based on the “primary mode of action” of the combination product, which means the mode of action expected to make the greatest contribution to the overall intended therapeutic effects. Thus, if the primary mode of action of a device-biologic combination product is attributable to the biologic product, that is, if it acts by means of a virus, therapeutic serum, |
toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, the FDA center responsible for premarket review of the biologic product would have primary jurisdiction for the combination product. |
• | distribution restricted to certain facilities or physicians with special training or experience; or |
• | distribution conditioned on the performance of specified medical procedures. |
• | The Centralized Procedure: an MA is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, and is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, and medicinal products containing a new active substance indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA on the date on which Regulation No. 726/2004 enters into force or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the European Union. |
• | The Mutual Recognition Procedure is mandatory when a product has already been authorized for marketing in a Member State of the EEA, known as the reference Member State, or RMS. This National MA needs to be recognized by the other Member States through the Mutual Recognition Procedure. |
• | The Decentralized Procedure: when the product has not received a National MA in any Member State at the time of application, it can be approved simultaneously in various Member States through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as the Reference Member State, or RMS. The competent authority of the RMS prepares a draft assessment report, a draft summary of the product characteristics, or SPC, and a draft of the labeling and package leaflet, which are sent to the other Member States (referred to as the Concerned Member States) for their approval. If the Concerned Member States raise no objections, based on a potential serious risk to public health, to the assessment, SPC, labeling, or packaging proposed by the RMS, the product is subsequently granted a national MA in all the Member States (i.e. in the RMS and the Concerned Member States). |
• | National marketing authorizations are issued by the competent authorities of the EEA Member States (e.g., for France, ANSM) and only cover their respective territories. They are available for products that are not covered by the compulsory scope of Community procedures. |
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order, or recommendation of, an item, good, facility or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. The intent standard under the federal Anti-Kickback Statute was amended by the ACA to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. 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; |
• | 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. 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. |
• | seek regulatory and marketing approvals and pursue commercial activities for Viaskin Peanut, and for which we continue to seek regulatory and marketing approvals in the United States; |
• | continue our research, pre-clinical and clinical development of our product candidates, including additional trials related to our pursuit of regulatory approval of Viaskin Peanut in the United States; |
• | seek regulatory and marketing approvals for our other product candidates that successfully complete clinical trials; |
• | establish a sales, marketing and distribution infrastructure to commercialize Viaskin Peanut, if approved, and any other products for which we may obtain marketing approval, especially in North America; |
• | further develop the manufacturing process for our product candidates, including any modifications to our patch technology; |
• | change or add additional manufacturers or suppliers; |
• | expand the scope of our current clinical trials for our product candidates; |
• | initiate and conduct any post-approval clinical trials, if required by the FDA, for our approved products, if any; |
• | initiate additional pre-clinical, clinical or other studies for our other product candidates; |
• | seek to identify and validate additional product candidates; |
• | acquire or in-license other product candidates and technologies; |
• | make milestone or other payments under any in-license agreements; |
• | maintain, protect and expand our intellectual property portfolio; |
• | attract and retain new and existing skilled personnel; |
• | add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts, as well as a company listed on both the U.S. and French stock markets; and |
• | experience any delays or encounter issues with any of the above. |
• | the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials; |
• | the approval of Viaskin Peanut by the EMA, FDA or other regulatory agencies; |
• | the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, especially in North America; |
• | the costs of securing manufacturing arrangements for commercial production; |
• | revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; |
• | the scope, prioritization and number of our research and development programs; |
• | the costs, timing and outcome of regulatory review of our product candidates; |
• | the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into; |
• | the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under our existing collaboration agreements and future collaboration agreements, if any; and |
• | the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights. |
• | 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 agency; |
• | 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 agency for marketing approval; |
• | the FDA or the applicable foreign regulatory agency may disagree with the number, design, size, conduct or implementation of our clinical trials; |
• | the FDA or the applicable foreign regulatory agency may require that we conduct additional clinical trials; |
• | the FDA or the applicable foreign regulatory agency 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 agency 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 either product candidate outweighs its respective safety risks; |
• | the FDA or the applicable foreign regulatory agency may disagree with our analysis or interpretation of data from our pre-clinical studies and clinical trials; |
• | the FDA or the applicable foreign regulatory agency 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 agency 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 agency may require development of a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval or post-approval; |
• | the FDA or the applicable foreign regulatory agency may restrict the use of our products to a narrow population; |
• | the FDA or the applicable foreign regulatory agency 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 agency may change its approval policies or adopt new regulations. Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market any of our product candidates based on our Viaskin technology platform. Moreover, because our business is almost entirely dependent upon Viaskin technology, any such setback in our pursuit of regulatory approval would have a material adverse effect on our business and prospects. |
• | a product candidate is ineffective, inferior to existing approved medicines, 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; |
• | the results may not confirm the positive results of earlier testing or trials; and |
• | the results may not meet the level of statistical significance required by the FDA or other regulatory agencies to establish the safety and efficacy of our product candidates. |
• | demonstrating sufficient safety and efficacy to obtain regulatory approval to commence a clinical trial; |
• | reaching agreement on acceptable terms with prospective CROs, and clinical trial sites; |
• | validating test methods to support quality testing of the drug substance and drug product; |
• | obtaining sufficient quantities of the drug substance or other materials necessary to conduct clinical trials; |
• | manufacturing sufficient quantities of a product candidate; |
• | obtaining permission to proceed from the FDA under an investigational new drug, or IND, application, or foreign equivalent approval from regulatory authorities outside the United States; |
• | obtaining institutional review board, or IRB, or independent ethics committee approval to conduct a clinical trial at a prospective clinical trial site; |
• | determining dosing and clinical design and making related adjustments; and |
• | patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical trial sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial, and which has been impacted by the ongoing COVID-19 pandemic. |
• | 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 patients 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; |
• | 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 and changes in regulatory requirements, policy and guidelines, including 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 patient enrollment, variability in the number and types of patients available for clinical trials, and lower-than anticipated retention rates for patients in clinical trials; |
• | difficulty in patient monitoring and data collection due to failure of patients to maintain contact after treatment; |
• | a regional disturbance where we or our collaborative partners are enrolling patients in our clinical trials, such as the ongoing COVID-19 pandemic or any other pandemic, 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 agencies. |
• | varying interpretations of data and commitments by the FDA and similar foreign regulatory agencies; and |
• | diminishment of any competitive advantages that such product candidates may have or attain. |
• | diminishment of any competitive advantages that such product candidates may have or attain; |
• | delays or termination in clinical trials or commercialization; |
• | refusal by the FDA or similar foreign regulatory agencies to review pending applications or supplements to approved applications; |
• | product recalls or seizures; |
• | suspension of manufacturing; |
• | withdrawals of previously approved marketing applications; and |
• | fines, civil penalties, and criminal prosecutions. |
• | our available capital resources or capital constraints we experience; |
• | our receipt of approvals, if any, by the FDA and other regulatory agencies 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; |
• | the securing of, costs related to, and timing issues associated with, product manufacturing, as well as sales and marketing activities; and |
• | impacts of the ongoing COVID-19 pandemic. |
• | 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. |
• | the third parties do not successfully carry out their contractual duties or fail to meet regulatory obligations or expected deadlines; |
• | we replace a third party; or |
• | the quality or accuracy of the data obtained by third parties is compromised due to their failure to adhere to clinical protocols, regulatory requirements, or for other reasons. |
• | 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. |
• | our inability to recruit, hire, retain and incentivize adequate numbers of effective sales and marketing personnel; |
• | the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future products; |
• | the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and |
• | unforeseen costs and expenses associated with establishing an independent sales and marketing organization. |
• | the demonstration of the clinical efficacy and safety of the product; |
• | the approved labeling for the product and any required warnings; |
• | the advantages and disadvantages of the product compared to alternative treatments; |
• | our and any collaborator’s ability to educate the medical community about the safety and effectiveness of the product; |
• | the coverage and reimbursement policies of government and commercial third-party payors pertaining to the product; |
• | the market price of our product relative to competing treatments; and |
• | our ability to effectively implement a scientific publication strategy. |
• | our ability or our collaborators’ ability to set a price we believe is fair for our products, if approved; |
• | our ability or our collaborators’ ability to obtain and maintain market acceptance by the medical community and patients; |
• | our ability to generate revenues and achieve profitability; and |
• | the availability of capital. |
• | 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. |
• | the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements; |
• | different medical practices and customs in foreign countries affecting acceptance in the marketplace; |
• | import or export licensing requirements; |
• | longer accounts receivable collection times; |
• | longer lead times for shipping; |
• | language barriers for technical training; |
• | reduced protection of intellectual property rights in some foreign countries, and related prevalence of generic alternatives to therapeutics; |
• | foreign currency exchange rate fluctuations; |
• | patients’ ability to obtain reimbursement for Viaskin patch products in foreign markets; and |
• | the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute. |
• | The federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for or the purchase, lease, order or recommendation of any item, good, facility or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. The intent standard under the federal Anti-Kickback Statute was amended by the ACA to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. 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. |
• | The federal civil and criminal false claims laws, including the civil False Claims Act, impose criminal and civil penalties, including those from civil whistleblower or qui tam actions, and civil monetary penalties laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. |
• | The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created federal criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters. 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. |
• | 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. |
• | 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 provide a basis for 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. |
• | 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. As a result, we could be prevented from commercializing current or future product candidates. |
• | cease developing, selling or otherwise commercializing our product candidates; |
• | pay substantial damages for past use of the asserted intellectual property; |
• | obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable terms, if at all; and |
• | in the case of trademark claims, redesign, or rename, Viaskin or other trademarks we may own, to avoid infringing the intellectual property rights of third parties, which may not be possible and, even if possible, could be costly and time-consuming. |
• | actual or anticipated fluctuations in our financial condition and operating results; |
• | actual or anticipated changes in our growth rate relative to our competitors; |
• | competition from existing products or new products that may emerge; |
• | regulatory actions with respect to our products or our competitors’ products, including the potential resubmission to the FDA of a BLA for Viaskin Peanut; |
• | announcements by us, our partners or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations, or capital commitments; |
• | failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public; |
• | issuance of new or updated research or reports by securities analysts; |
• | fluctuations in the valuation of companies perceived by investors to be comparable to us; |
• | price and volume fluctuations attributable to inconsistent trading volume levels of the ADSs and/or ordinary shares; |
• | additions or departures of key management or scientific personnel; |
• | disputes or other developments related to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; |
• | changes in the structure of healthcare payment systems; |
• | changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels; |
• | announcement or expectation of additional debt or equity financing efforts; |
• | sales of our ordinary shares or ADSs by us, our insiders or our other shareholders; and |
• | general economic and market conditions, including as a result of the ongoing COVID-19 pandemic. |
• | under French law, a non-French resident as well as any French entity controlled by non-French residents may have to file a declaration for statistical purposes with the Banque de France |
• | under French law, certain investments in a French company relating to certain strategic industries by individuals or entities not residents in a Member State of the EU are subject to prior authorization of the Ministry of Economy; |
• | the owner of 90% of the share capital and voting rights of a public company listed on a regulated market in a Member State of the European Union or in a state party to the EEA Agreement, including from the main French Stock Exchange, has the right to force out minority shareholders following a tender offer made to all shareholders; |
• | a merger (i.e., in a French law context, a share for share exchange following which our company would be dissolved into the acquiring entity and our shareholders would become shareholders of the acquiring entity) of our company into a company incorporated in the European Union would require the approval of our board of directors as well as a two-thirds majority of the votes held by the shareholders present, represented by proxy or voting by mail at the relevant meeting; |
• | under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder; |
• | our shareholders have granted and may grant in the future our board of directors’ broad authorizations to increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, including as a possible defense following the launching of a tender offer for our shares; |
• | our shareholders have preferential subscription rights on a pro rata basis on the issuance by us of any additional securities for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of our shareholders or on an individual basis by each shareholder; |
• | our board of directors has the right to appoint directors to fill a vacancy created by the resignation or death of a director, subject to the approval by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on our board of directors; |
• | our board of directors can only be convened by our chairman or our managing director, if any, or, when no board meeting has been held for more than two consecutive months, by directors representing at least one-third of the total number of directors; |
• | our board of directors meetings can only be regularly held if at least half of the directors attend either physically or by way of videoconference or teleconference enabling the directors’ identification and ensuring their effective participation in the board’s decisions; however, this mode of participation (by way of videoconference or teleconference) does not apply to the adoption of decisions taken for the closing of the accounts for the fiscal year, including the consolidated financial statements; |
• | our shares are nominative or bearer, if the legislation so permits, according to the shareholder’s choice. 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. |
• | not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404; |
• | reduced disclosure obligations regarding financial information; and |
• | reduced disclosure obligations regarding executive compensation. |
• | On February 22, 2021, the issuance of 7,500 ordinary shares to a non-U.S. employee upon exercise of 7,500 employee warrants (“bons de souscription de parts de créateur d’entreprise,” or “BSPCEs”) at an exercise price of 5.13 euros per warrant, for aggregate proceeds to the Company of 38,475 euros; |
• | On March 23, 2021, the grant of an aggregate of 4,000 RSUs to a non-U.S. employee; |
• | On March 23, 2021, the grant of an aggregate of 2,200 stock options to a non-U.S. employee. Each stock option is exercisable at an exercise price of 9.30 euros; |
• | On May 12, 2021, the issuance of 10,200 ordinary shares to a non-U.S. employee upon exercise of 10,200 BSAs at an exercise price of 5.13 euros per warrant, for aggregate proceeds to the Company of 52,236 euros; |
• | On May 17, 2021, the issuance of 10,500 ordinary shares to a non-U.S. employee upon exercise of 10,500 BSAs at an exercise price of 5.13 euros per warrant, for aggregate proceeds to the Company of 53,865 euros; |
• | On May 18, 2021, the issuance of 10,800 ordinary shares to a non-U.S. employee upon exercise of 10,800 BSAs at an exercise price of 5.13 euros per warrant, for aggregate proceeds to the Company of 55,404 euros; |
• | On May 19, 2021, the grant of an aggregate of 20,000 RSUs to a non-U.S. employee; |
• | On May 21, 2021, the issuance of 11,100 ordinary shares to a non-U.S. employee upon exercise of 11,100 BSAs at an exercise price of 5.13 euros per warrant, for aggregate proceeds to the Company of 56,943 euros; |
• | On May 26, 2021, the issuance of 21,000 ordinary shares to a non-U.S. employee upon exercise of 21,000 non-employee warrants (“bons de souscription d’action,” or “BSAs”) at an exercise price of 5.13 euros per warrant, for aggregate proceeds to the Company of 107,730 euros; |
• | On May 28, 2021, the issuance of 11,400 ordinary shares to a non-U.S. employee upon exercise of 11,400 BSAs at an exercise price of 5.13 euros per warrant, for aggregate proceeds to the Company of 58,482 euros; |
• | On June 3, 2021, the grant of an aggregate of 39,185 BSAs to a Directors for aggregate proceeds to the Company of 229,232 euros. Each BSA is exercisable for one ordinary share at an exercise price of 10.75 euros; |
• | On October 7, 2021, the issuance of an aggregate of 20,000 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
• | On November 22, 2021, the grant of an aggregate of 153,800 RSUs to a non-U.S. employee; |
• | On November 22, 2021, the grant of an aggregate of 432,100 stock options to a non-U.S. employee. Each stock option is exercisable at an exercise price of 5.87 euros; |
• | On November 22, 2021, the grant of an aggregate of 13,700 RSUs to our executive officers; |
• | On November 22, 2021, the grant of an aggregate of 420,400 stock options to our executive officers. Each stock option is exercisable at an exercise price of 5.87 euros; |
• | On November 24, 2021, the issuance of an aggregate of 58,675 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
• | On December 20, 2021, the issuance of an aggregate of 5,400 ordinary shares to a non-U.S. employee upon settlement of RSUs. |
• | continue our research, pre-clinical and clinical development of our product candidates, including expanding the scope of our trials for Viaskin Peanut; |
• | seek regulatory and marketing approvals and pursue commercial activities for Viaskin Peanut, especially in North America and in the European Union; |
• | seek regulatory and marketing approvals for our other product candidates that successfully complete clinical trials; |
• | continue to establish a sales, marketing and distribution infrastructure to commercialize Viaskin Peanut, if approved, and any other products for which we may obtain marketing approval, especially in North America and in the European Union; |
• | further develop the manufacturing process for our product candidates; |
• | change or add additional manufacturers or suppliers; |
• | initiate and conduct any post-approval clinical trials, if required by the FDA or by the EMA, for our approved products, if any; |
• | initiate additional pre-clinical, clinical or other studies for our product candidates; |
• | seek to identify and validate additional product candidates; |
• | acquire or in-license other product candidates and technologies; |
• | make milestone or meet other payments deadlines under any in-license agreements; |
• | maintain, protect and expand our intellectual property portfolio; |
• | attract and retain new and existing skilled personnel; |
• | add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts, as well as a company listed on both the U.S. and French stock markets; |
• | handle impacts of the ongoing COVID-19 pandemic; and |
• | experience any delays or encounter issues with any of the above. |
• | 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. |
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
(thousands of U.S. Dollars) |
||||||||
Research and development expenses related to Viaskin Peanut (1) |
$ | 47,961 | $ | 70,507 | ||||
As a percentage of research and development expenses, excluding share-based compensation expense |
70 | % | 70 | % | ||||
Research and development expenses related to Viaskin Milk (1) |
$ | 5,861 | $ | 4,750 | ||||
As a percentage of research and development expenses excluding share-based compensation expense |
9 | % | 5 | % | ||||
Other research and development expenses (1) |
$ | 14,868 | $ | 25,735 | ||||
Total research and development expenses, excluding share-based compensation expense |
$ | 68,690 | $ | 100,991 | ||||
Share-based compensation expenses included in research and development expenses |
$ | 1,646 | $ | ,616 | ||||
Total research and development expenses |
$ |
70,336 |
$ |
101,607 |
(1) | Excludes employee share-based compensation expense. |
• | the FDA’s approval of our BLA for Viaskin Peanut; |
• | the costs of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, especially in North America; |
• | the costs of securing manufacturing arrangements for commercial production; |
• | revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; |
• | the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials; |
• | the scope, prioritization and number of our research and development programs; |
• | the costs, timing and outcome of regulatory review of our product candidates; |
• | the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into; |
• | the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under our existing collaboration agreements and future collaboration agreements, if any; and |
• | the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights. |
December 31, |
||||||||||||||||
(Dollar amounts presented in thousands, except per share amounts) |
2021 |
2020 |
$ change |
% change |
||||||||||||
Operating income |
$ |
5,708 |
$ |
11,276 |
(5,568 |
) |
(49 |
%) | ||||||||
Operating expenses |
||||||||||||||||
Research and development expenses |
(70,336 | ) | (101,607 | ) | 31,271 | (31 | %) | |||||||||
Sales and marketing expenses |
(4,387 | ) | (9,879 | ) | 5,492 | (56 | %) | |||||||||
General and administrative expenses |
(30,520 | ) | (35,081 | ) | 4,561 | (13 | %) | |||||||||
Restructuring income (expenses) |
920 | (23,552 | ) | 24,472 | (104 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Operating expenses |
(104,323 | ) | (170,118 | ) | 65,795 | (39 | %) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Financial income (expense) |
425 | (724 | ) | 1,149 | (159 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income tax |
381 | 10 | 371 | * | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ |
(97,809 |
) |
$ |
(159,555 |
) |
61,747 |
(39 |
%) | |||||||
|
|
|
|
|
|
|
|
|||||||||
Basic/diluted Net loss per share attributable to shareholders |
(1.78 | ) | (2.95 | ) |
* |
Percentage not meaningful |
December 31, |
||||||||||||||||
(Dollar amounts presented in thousands) |
2021 |
2020 |
$ change |
% change |
||||||||||||
Sales |
— | — | ||||||||||||||
Other income |
5,708 | 11,276 | (5,568 | ) | (49 | %) | ||||||||||
Research tax credit |
7,505 |
9,930 |
(2,425 | ) | (24 | %) | ||||||||||
Other operating (loss) income |
(1,797 |
) |
1,346 |
(3,142 | ) | (234 | %) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating income |
5,708 |
11,276 |
(5,568 |
) |
(49 |
%) | ||||||||||
|
|
|
|
|
|
|
|
December 31, |
||||||||||||||||
(Dollar amounts presented in thousands) |
2021 |
2020 |
$ change |
% change |
||||||||||||
Research and development expenses |
||||||||||||||||
External clinical-related expenses |
39,386 | 48,721 | (9,335 | ) | (19 | %) | ||||||||||
Employee-related costs excl. share-based payment expenses |
12,950 | 25,087 | (12,137 | ) | (48 | %) | ||||||||||
Share-based payment expenses |
1,646 | 616 | 1,030 | 167 | % | |||||||||||
Depreciation, amortization and other costs |
16,354 | 27,183 | (10,829 | ) | (40 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Research and development expenses |
70,336 |
101,607 |
(31,271 |
) |
(31 |
%) | ||||||||||
|
|
|
|
|
|
|
|
December 31, |
||||||||||||||||
(Dollar amounts presented in thousands) |
2021 |
2020 |
$ change |
% change |
||||||||||||
Sales and marketing expenses |
||||||||||||||||
External professional services expenses |
1,577 | 3,216 | (1,639 | ) | (51 | %) | ||||||||||
Employee-related costs excl. share-based payment expenses |
1,573 | 7,334 | (5,761 | ) | (79 | %) | ||||||||||
Share-based payment expenses (income) |
312 | (2,117 | ) | 2,429 | (115 | %) | ||||||||||
Depreciation, amortization and other costs |
925 | 1,446 | (521 | ) | (36 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Sales and marketing expenses |
4,387 |
9,879 |
(5,492 |
) |
(56 |
%) | ||||||||||
|
|
|
|
|
|
|
|
December 31, |
||||||||||||||||
(Dollar amounts presented in thousands) |
2021 |
2020 |
$ change |
% change |
||||||||||||
General and administrative expenses |
||||||||||||||||
External professional services fees |
7,944 | 12,684 | (4,740 | ) | (37 | %) | ||||||||||
Employee-related costs excl. share-based payment expenses |
8,194 | 9,534 | (1,339 | ) | (14 | %) | ||||||||||
Share-based payment expenses |
1,163 | 372 | 791 | 213 | % | |||||||||||
Depreciation, amortization and other costs |
13,219 | 12,492 | (727 | ) | (6 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total General and administrative expenses |
30,520 |
35,081 |
(4,561 |
) |
(13 |
%) | ||||||||||
|
|
|
|
|
|
|
|
December 31, |
||||||||
(Amounts in thousands of U.S. Dollars) |
2021 |
2020 |
||||||
Employee-related (income) expenses |
(920 | ) | 19,194 | |||||
Effects of restructuring on leases |
— | 2,028 | ||||||
Other restructuring costs |
— | 2,330 | ||||||
|
|
|
|
|||||
Total restructuring (income) expenses |
(920 |
) |
23,552 |
|||||
|
|
|
|
(Amounts in thousands of U.S. Dollars) |
Restructuring liabilities |
|||
Restructuring liability—January 1, 2020 |
— | |||
Restructuring costs |
23,552 | |||
Restructuring costs—non cash items |
(2,028 | ) | ||
Amounts paid |
(12,137 | ) | ||
|
|
|||
Restructuring liability—December 31, 2020 |
9,387 |
|||
|
|
|||
of which current contingencies |
1,993 |
|||
of which other current liabilities |
7,394 |
Restructuring liabilities |
||||
Restructuring liability—January 1, 2021 |
9,387 | |||
Restructuring costs |
— | |||
Amounts paid |
(7,747 | ) | ||
Reversal of contingencies |
(920 | ) | ||
Other effect including currency translation effect |
(282 | ) | ||
|
|
|||
Restructuring liability—December 31, 2021 |
438 |
|||
|
|
|||
of which current contingencies |
— |
|||
of which other current liabilities |
438 |
Equity capital |
Bank Loans |
Other debt |
Total |
|||||||||||||
(Amounts in thousands of U.S. Dollars) |
||||||||||||||||
2020 |
150,010 | — | — | 150,010 | ||||||||||||
2021 |
— | — | — | — | ||||||||||||
Total |
150,010 |
— |
— |
150,010 |
Material Cash Requirements Due by the Year Ended December 31, |
||||||||||||||||||||
2022 |
2023-2024 |
2025-2026 |
Thereafter |
Total |
||||||||||||||||
(Amounts in thousands) |
||||||||||||||||||||
Conditional advances |
510 | — | — | — | 510 | |||||||||||||||
Operating leases |
3,003 | 4,715 | 1,343 | 1,089 | 10,150 | |||||||||||||||
Purchase obligations—Obligations Under the Terms of CRO Agreements |
22,840 | 7,455 | — | — | 30,294 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total |
26,353 | 12,170 | 1,343 | 1,089 | 40,954 |
December 31, |
$ change |
% change |
||||||||||||||
(Amounts in thousands of U.S. Dollars) |
2021 |
2020 |
||||||||||||||
Net cash flows used in operating activities |
(108,242 | ) | (165,607 | ) | 57,365 | (35 | %) | |||||||||
Net cash flows used in investing activities |
(433 | ) | (2,865 | ) | 2,433 | (85 | %) | |||||||||
Net cash flows provided by financing activities |
274 | 149,548 | (149,273 | ) | (100 | %) | ||||||||||
Effect of exchange rate changes on cash and cash equivalents |
(10,651 | ) | 22,022 | (32,673 | ) | (148 | %) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Net (decrease) increase in cash and cash equivalents |
(119,051 |
) |
3,097 |
(122,149 |
) |
* |
||||||||||
|
|
|
|
|
|
|
|
* | Percentage not meaningful |
Assumptions per year ended December 31, |
||||||||
Stock options per grant date |
2020 |
2021 |
||||||
Weighted average shares price at grant date (in €) |
5.54 | 5.71 | ||||||
Weighted average expected volatility |
87.3 | % | 90.2 | % | ||||
Weighted average risk-free interest rate |
(0.5 | )% | (0.06 | )% | ||||
Weighted average expected term (in years) |
6.0 | 6.0 | ||||||
Dividend yield |
0 | 0 | ||||||
Weighted average fair value of stock-options (in €) |
3,90 | 4,17 |
* | 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. |
Weighted average share price at grant date (in €) |
10.75 | |||
Weighted average expected volatility |
90.0 | % | ||
Weighted average risk-free interest rate |
(0.53 | )% | ||
Weighted average expected term (in years) |
3.21 | |||
Dividend yield |
— | |||
Weighted average fair value of warrants (in €) |
— |
Incorporated by Reference |
||||||||||||||||||
Exhibit |
Description |
Schedule/ Form |
File Number |
Exhibit |
File Date |
|||||||||||||
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||||||||||
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||||||||||||
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |||||||||||||||||
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||||||||||
104* | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
* | Filed herewith. |
** | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. |
† | Indicates a management contract or any compensatory plan, contract or arrangement. |
# | Confidential treatment has been granted from the Securities and Exchange Commission as to certain portions of this document. |
DBV Technologies S.A. |
/s/ Daniel Tassé |
Name: Daniel Tassé |
Title: Chief Executive Officer |
(Principal Executive Officer) |
Signature |
Title | |
/s/ Daniel Tassé Daniel Tassé |
Chief Executive Officer and Director ( Principal Executive Officer | |
/s/ Sebastién Robitaille Sebastién Robitaille |
Chief Financial Officer ( Principal Financial and Accounting Officer | |
/s/ Michel de Rosen Michel de Rosen |
Director | |
/s/ Mailys Ferrere Mailys Ferrere |
Director | |
/s/ Michael J. Goller Michael J. Goller |
Director | |
/s/ Viviane Monges Viviane Monges |
Director | |
/s/ Timothy E. Morris Timothy E. Morris |
Director |
Signature |
Title | |
/s/ Adora Ndu Adora Ndu |
Director | |
/s/ Julie O’Neill Julie O’Neill |
Director | |
/s/ Ravi Madduri Rao Ravi Madduri Rao |
Director | |
/s/ Daniel Soland Daniel Soland |
Director |
• |
We obtained an understanding and tested the design and implementation of the internal control related to the Company’s going concern assessment; |
• |
We evaluated the reasonableness of the Company’s forecasted operating expenses by obtaining an understanding of the Company’s operations and strategy, inquiring about the Company’s research and development activities, comparing the forecasted operating expenses to historical operating expenses and assessing expected costs, especially those costs that relate to future clinical trials; |
• |
We assessed management’s ability to forecast operating expenses by comparing prior year forecasts to actual financial results; |
• |
We assessed the adequacy of the consolidated financial statements’ disclosure related to the going concern assessment. |
/s/ |
||
/s/ Cédric Adens |
Partner | ||
We have served as the Company’s auditor since 2011. |
We have served as the Company’s auditor since 2020. |
Year ended December 31, |
||||||||||||
Note |
2021 |
2020 |
||||||||||
Assets |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
3 |
$ | $ | |||||||||
Trade receivables |
4 |
|||||||||||
Other current assets |
5 |
|||||||||||
|
|
|
|
|||||||||
Total current assets |
||||||||||||
Property, plant, and equipment, net |
6 |
|||||||||||
Right-of-use |
7 |
|||||||||||
Intangible assets |
||||||||||||
Other non-current assets |
8 |
|||||||||||
|
|
|
|
|||||||||
Total non-current assets |
||||||||||||
|
|
|
|
|||||||||
Total Assets |
$ |
$ |
||||||||||
|
|
|
|
|||||||||
Liabilities and shareholders’ equity |
||||||||||||
Current liabilities |
||||||||||||
Trade payables |
9 |
$ | $ | |||||||||
Short-term operating leases |
7 |
|||||||||||
Short-term financial debt |
10 |
|||||||||||
Current contingencies |
14 |
|||||||||||
Other current liabilities |
9 |
|||||||||||
|
|
|
|
|||||||||
Total current liabilities |
||||||||||||
Long-term operating leases |
7 |
|||||||||||
Long-term financial debt |
10 |
|||||||||||
Non-current contingencies |
14 |
|||||||||||
Other non-current liabilities |
10 |
|||||||||||
|
|
|
|
|||||||||
Total non-current liabilities |
||||||||||||
|
|
|
|
|||||||||
Total liabilities |
$ |
$ |
||||||||||
|
|
|
|
|||||||||
Shareholders’ equity: |
||||||||||||
Ordinary shares, € |
$ | $ | ||||||||||
Additional paid-in capital |
||||||||||||
Treasury stock, |
( |
) | ( |
) | ||||||||
Accumulated deficit |
( |
) | ( |
) | ||||||||
Accumulated other comprehensive income |
||||||||||||
Accumulated currency translation effect |
( |
) | ||||||||||
|
|
|
|
|||||||||
Total shareholders’ equity |
12 |
$ |
$ |
|||||||||
|
|
|
|
|||||||||
Total liabilities and shareholders’ equity |
$ |
$ |
||||||||||
|
|
|
|
Year ended December 31, |
||||||||||
Note |
2021 |
2020 |
||||||||
Operating income |
15 |
$ |
$ |
|||||||
Operating expenses |
||||||||||
Research and development expenses |
16 |
( |
) | ( |
) | |||||
Sales & marketing expenses |
16 |
( |
) | ( |
) | |||||
General & administrative expenses |
16 |
( |
) | ( |
) | |||||
Restructuring reversal (expenses) |
2,16 |
( |
) | |||||||
|
|
|
|
|||||||
Total Operating expenses |
( |
) | ( |
) | ||||||
|
|
|
|
|||||||
Loss from operations |
( |
) |
( |
) | ||||||
|
|
|
|
|||||||
Financial income (expenses) |
( |
) | ||||||||
|
|
|
|
|||||||
Loss before taxes |
( |
) |
( |
) | ||||||
|
|
|
|
|||||||
Income tax |
17 |
|||||||||
|
|
|
|
|||||||
Net loss |
$ |
( |
) |
$ |
( |
) | ||||
|
|
|
|
|||||||
Foreign currency translation differences, net of taxes |
( |
) | ||||||||
Actuarial gains on employee benefits, net of taxes |
||||||||||
|
|
|
|
|||||||
Total comprehensive loss |
$ |
( |
) |
$ |
( |
) | ||||
|
|
|
|
|||||||
Basic/diluted Net loss per share attributable to shareholders |
20 |
$ |
( |
) |
$ |
( |
) | |||
Weighted average number of shares outstanding used in computing per share amounts: |
20 |
Year ended December 31, |
||||||||||||
Notes |
2021 |
2020 |
||||||||||
Net loss for the period |
$ |
( |
) |
$ |
( |
) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation, amortization and accrued contingencies |
||||||||||||
Retirement pension obligations |
( |
) | ||||||||||
Expenses related to share-based payments |
( |
) | ||||||||||
Other elements |
||||||||||||
Changes in operating assets and liabilities: |
||||||||||||
Decrease (increase) in inventories and work in progress |
||||||||||||
Decrease (increase) in trade receivables |
( |
) | ||||||||||
Decrease (increase) in other current assets |
( |
) | ( |
) | ||||||||
(Decrease) increase in trade payables |
( |
) | ( |
) | ||||||||
(Decrease) increase in other current and non-current liabilities |
( |
) | ( |
) | ||||||||
Change in operating lease liabilities and right of use assets |
( |
) | ||||||||||
Net cash flow used in operating activities |
( |
) |
( |
) | ||||||||
|
|
|
|
|||||||||
Cash flows used in investing activities: |
||||||||||||
Acquisitions of property, plant, and equipment |
( |
) | ( |
) | ||||||||
Proceeds from property, plant, and equipment dispositions |
||||||||||||
Acquisitions of intangible assets |
( |
) | ( |
) | ||||||||
Acquisitions of non-current financial assets |
( |
) | ( |
) | ||||||||
|
|
|
|
|||||||||
Net cash flows used in investing activities |
( |
) |
( |
) | ||||||||
|
|
|
|
|||||||||
Cash flows provided by financing activities: |
||||||||||||
(Decrease) increase in conditional advances |
( |
) | ( |
) | ||||||||
Treasury shares |
( |
) | ||||||||||
Capital increases, net of transaction costs |
||||||||||||
Other cash flows related to financing activities |
( |
) | ( |
) | ||||||||
|
|
|
|
|||||||||
Net cash flows provided by financing activities |
||||||||||||
|
|
|
|
|||||||||
Effect of exchange rate changes on cash and cash equivalents |
( |
) | ||||||||||
|
|
|
|
|||||||||
Net (decrease) / increase in cash and cash equivalents |
( |
) |
||||||||||
|
|
|
|
|||||||||
Net cash and cash equivalents at the beginning of the period |
||||||||||||
|
|
|
|
|||||||||
Net cash and cash equivalents at the end of the period |
3 |
$ |
$ |
|||||||||
|
|
|
|
Ordinary shares |
||||||||||||||||||||||||||||||||
Number of Shares Note 12 |
Amount |
Additional paid-in capital |
Treasury stock |
Acc. deficit |
Acc. other comprehensive income |
Acc. currency translation effect |
Total Equity |
|||||||||||||||||||||||||
Balance at January 1, 2020 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Net (loss) |
— |
— |
— |
— |
( |
) |
— | — | ( |
) | ||||||||||||||||||||||
Other comprehensive income (loss) |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||
Issuance of ordinary shares |
— |
— |
— |
— | ||||||||||||||||||||||||||||
Treasury shares |
— |
— |
— |
( |
) |
— |
— |
— | ( |
) | ||||||||||||||||||||||
Share-based payments (income) expenses |
— |
— |
( |
) |
— |
— |
— |
— | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at December 31, 2020 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
$ |
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Net (loss) |
( |
) |
( |
) | ||||||||||||||||||||||||||||
Other comprehensive (loss) |
( |
) |
( |
) | ||||||||||||||||||||||||||||
Issuance of ordinary shares |
||||||||||||||||||||||||||||||||
Issuance of share warrants |
— |
— |
— |
— | — | — | ||||||||||||||||||||||||||
Treasury shares |
( |
) |
( |
) | ||||||||||||||||||||||||||||
Share-based payments (income) expenses |
||||||||||||||||||||||||||||||||
Allocation of accumulated net losses |
— |
— |
( |
) |
— | — | — | — | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at December 31, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
• | DBV Technologies Inc. was incorporated in Delaware on |
• | DBV Australia Pty Ltd. was incorporated in New South Wales, Australia on |
• | DBV Pharma was incorporated in Paris on |
PROPERTY, PLANT, AND EQUIPMENT ITEM PERIOD |
DEPRECIATION |
|||
Fixtures and leasehold improvements |
|
| ||
Research and development / production tools |
|
| ||
Research equipment and technical facilities |
|
| ||
Computer equipment |
|
| ||
Office equipment and furniture |
|
|
• |
Level 1—Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. |
• |
Level 2—Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined through the use of models or other valuation methodologies. |
• |
Level 3—Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability. |
• | discount rate; |
• | future salary increases; |
• | employee turnover; and |
• | mortality tables. |
• | information available before the consolidated financial statements are issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the consolidated financial statements; and |
• | the amount of loss can be reasonably estimated. |
1. | Identify a modified Viaskin patch (which the Company calls mVP). |
2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
3. | Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies: |
a. | PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL |
b. |
‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP. |
December 31, |
||||||||
2021 |
2020 |
|||||||
Employee-related expenses (income) |
( |
) | ||||||
Effects of restructuring on leases |
||||||||
Other restructuring costs |
||||||||
|
|
|
|
|||||
Total restructuring costs |
( |
) |
||||||
|
|
|
|
(Amounts in thousands of U.S. Dollars) |
||||
Restructuring liabilities |
||||
Restructuring liability — January 1, 2020 |
||||
Restructuring costs |
||||
Restructuring costs — non cash items |
( |
) | ||
Amounts paid |
( |
) | ||
|
|
|||
Restructuring liability — December 31, 2020 |
||||
|
|
|||
of which current contingencies |
||||
of which other current liabilities |
||||
Restructuring liabilities |
||||
Restructuring liability — January 1, 2021 |
||||
Restructuring costs |
||||
Amounts paid |
( |
) | ||
Reversal of contingencies |
( |
) | ||
Other effect including currency translation effect |
( |
) | ||
|
|
|||
Restructuring liability — December 31, 2021 |
||||
|
|
|||
of which current contingencies |
— | |||
of which other current liabilities |
December 31, |
||||||||
2021 |
2020 |
|||||||
Cash |
||||||||
Cash equivalent |
||||||||
|
|
|
|
|||||
Total cash and cash equivalent as reported in statement of financial position |
||||||||
|
|
|
|
|||||
Bank overdrafts |
||||||||
|
|
|
|
|||||
Total net cash and cash equivalents as reported in the statement of cash flow |
||||||||
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
Research tax credit |
— | |||||||
Other tax claims |
||||||||
Prepaid expenses |
||||||||
Other receivables |
||||||||
|
|
|
|
|||||
Total |
||||||||
|
|
|
|
Amount in thousands of US Dollars |
||||
Opening balance sheet receivable as of January 1, 2020 |
||||
+ 2020 fiscal year research tax credit |
||||
- Payment received |
||||
- Currency translation effect |
||||
|
|
|||
Closing balance sheet receivable as of December 31, 2020 |
||||
|
|
|||
Of which — Non-current portion |
||||
Of which — Current portion |
||||
|
|
|
| |
Amount in thousands US Dollars |
||||
Opening balance sheet receivable as of January 1, 2021 |
||||
+ 2021 fiscal year research tax credit |
||||
- Payment received |
||||
- Adjustment and currency translation effect |
( |
) | ||
|
|
|||
Closing balance sheet receivable as of December 31, 2021 |
||||
|
|
|||
Of which —Non -current portion |
||||
Of which —Current portion |
1/1/2020 |
Currency translation effect |
Increase |
Decrease |
12/31/2020 |
||||||||||||||||
Laboratory equipment |
( |
) | ||||||||||||||||||
Building fixtures |
( |
) | ||||||||||||||||||
Office equipment |
— | |||||||||||||||||||
Computer equipment |
( |
) | ||||||||||||||||||
Property, plant, and equipment in progress |
( |
) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total, gross |
( |
) |
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Less accumulated amortization and depreciation |
( |
) | ( |
) | ( |
) | — | ( |
) | |||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total, net |
( |
) |
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
1/1/2021 |
Currency translation effect |
Increase |
Decrease |
12/31/2021 |
||||||||||||||||
Laboratory equipment |
( |
) | ( |
) | ||||||||||||||||
Building fixtures |
( |
) | ( |
) | ||||||||||||||||
Office equipment |
( |
) | — | ( |
) | |||||||||||||||
Computer equipment |
( |
) | ( |
) | ||||||||||||||||
Property, plant, and equipment in progress |
( |
) | ( |
) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total, gross |
( |
) |
( |
) |
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Less accumulated amortization and depreciation |
( |
) | ( |
) | ( |
) | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total, net |
( |
) |
( |
) |
( |
) |
||||||||||||||
|
|
|
|
|
|
|
|
|
|
December 31, 2021 |
December 31, 2020 |
|||||||||||||||||||||||
Real estate |
Other assets |
Total |
Real estate |
Other assets |
Total |
|||||||||||||||||||
Current portion |
||||||||||||||||||||||||
Year 2 |
||||||||||||||||||||||||
Year 3 |
||||||||||||||||||||||||
Year 4 |
||||||||||||||||||||||||
Year 5 |
||||||||||||||||||||||||
Thereafter |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total minimum lease payments |
||||||||||||||||||||||||
Less: Effects of discounting |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Present value of operating lease |
||||||||||||||||||||||||
Less: current portion |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Long-term operating lease |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Weighted average remaining lease term (years) |
||||||||||||||||||||||||
Weighted average discount rate |
% | % | % | % |
December 31, |
||||||||
2021 |
2020 |
|||||||
Operating lease expense |
||||||||
Restructuring expense |
December 31, |
||||||||
2021 |
2020 |
|||||||
Cash paid for amounts included in the measurement of lease liabilities |
||||||||
Operating cash flows from operating leases |
December 31, |
||||||||
2021 |
2020 |
|||||||
Research tax credit |
||||||||
Pledged securities |
||||||||
Deposits and other non-current financial assets |
||||||||
Liquidity contract |
||||||||
|
|
|
|
|||||
Total other non-current assets |
||||||||
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
Social debt |
||||||||
Deferred income |
||||||||
Tax liabilities |
||||||||
Other debts |
||||||||
|
|
|
|
|||||
Total |
||||||||
|
|
|
|
BPI advance |
||||
Balance sheet debt at start of period 01/01/2020 |
||||
Repayments |
( |
) | ||
Other including currency translation effect |
||||
|
|
|||
Balance sheet debt as at 12/31/2020 |
||||
|
|
|||
Of which — Non-current portion |
||||
Of which — Current portion |
||||
Stated interest rate |
||||
Discount rate |
% | |||
Maturity (in years) |
BPI advance |
||||
Balance sheet debt at start of period 01/01/2021 |
||||
Repayments |
( |
) | ||
Other including currency translation effect |
( |
) | ||
|
|
|||
Balance sheet debt as at 12/31/2021 |
||||
|
|
|||
Of which — Non-current portion |
||||
Of which — Current portion |
||||
Stated interest rate |
||||
Discount rate |
% | |||
Maturity (in years) |
Carrying |
2022 |
2023 |
Thereafter |
|||||||||||||
Short-term financial debt — Conditional advances |
— | — | ||||||||||||||
Other liabilities |
— | |||||||||||||||
Supplier accounts payable and related payables |
— | — | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total liabilities |
— |
|||||||||||||||
|
|
|
|
|
|
|
|
Date |
Nature of the transactions |
Share capital * |
Additional paid-in capital |
Number of shares |
||||||||||
Balance as of January 1, 2020 |
|
|||||||||||||
1/16/2020 |
Capital increase by employee warrants | |
||||||||||||
1/16/2020 |
Capital increase by stock options | |
||||||||||||
02/04/2020 |
Capital increase by global offering | |
||||||||||||
02/04/2020 |
Fees charged to share premium | — | |
( |
) | |||||||||
03/04/2020 |
Capital increase by global offering | |
||||||||||||
03/04/2020 |
Fees charged to share premium | — | |
( |
) | — | ||||||||
9/30/2020 |
Fees charged to share premium | — | |
( |
) | — | ||||||||
11/25/2020 |
Capital increase by RSU | — | |
— | ||||||||||
12/31/2020 |
Share-based payments | — | |
( |
) | — | ||||||||
|
|
|
|
|
|
|
||||||||
Balance as of December 31, 2020 |
|
|||||||||||||
|
|
|
|
|
|
|
||||||||
02/22/2021 |
Capital increase by employee warrants | |
||||||||||||
05/12/2021 |
Capital increase by employee warrants | |
||||||||||||
05/17/2021 |
Capital increase by employee warrants | |
||||||||||||
05/18/2021 |
Capital increase by employee warrants | |
||||||||||||
05/19/2021 |
Retained earnings charged on share premium | |
( |
) | ||||||||||
05/21/2021 |
Capital increase by employee warrants | |
||||||||||||
05/26/2021 |
Capital increase by employee warrants | |
||||||||||||
05/28/2021 |
Capital increase by employee warrants | |
||||||||||||
06/10/2021 |
Issuance of share warrants | |
||||||||||||
10/07/2021 |
Capital increase by ordinary shares | |
( |
) | ||||||||||
11/24/2021 |
Capital increase by ordinary shares | |
( |
) | ||||||||||
12/20/2021 |
Capital increase by ordinary shares | |
( |
) | ||||||||||
12/31/2021 |
Share-based payments | |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||
Balance as of December 31, 2021 |
|
|||||||||||||
|
|
|
|
|
|
|
* | Conversion in U.S. Dollars at historical rates |
Share-based payments instrument |
General meeting of shareholders |
Board of directors meeting |
Grant date |
Number granted |
||||||
BSA |
||||||||||
BSA |
||||||||||
SO |
BSA |
||||||||||
SO |
||||||||||
BSA |
||||||||||
BSA |
||||||||||
SO |
||||||||||
SO |
||||||||||
BSA |
||||||||||
SO |
||||||||||
SO |
||||||||||
BSA |
||||||||||
SO |
||||||||||
RSU |
||||||||||
RSU |
||||||||||
BSA |
||||||||||
SO |
||||||||||
SO |
||||||||||
SO |
||||||||||
SO |
||||||||||
BSA |
||||||||||
RSU |
||||||||||
RSU |
||||||||||
SO |
||||||||||
SO |
||||||||||
RSU |
||||||||||
SO |
||||||||||
RSU |
||||||||||
RSU |
||||||||||
SO |
||||||||||
RSU |
||||||||||
SO |
||||||||||
SO |
||||||||||
SO |
||||||||||
RSU |
||||||||||
SO |
||||||||||
RSU |
||||||||||
RSU |
||||||||||
RSU |
||||||||||
SO |
||||||||||
RSU |
||||||||||
SO |
||||||||||
RSU |
||||||||||
BSA |
||||||||||
RSU |
||||||||||
SO |
Warrant fair value assumptions during the year ended December 31, 2021 |
| |||
|
||||
Weighted average share price at grant date ( in €) |
||||
Weighted average expected volatility |
% | |||
Weighted average risk-free interest rate |
( |
)% | ||
Weighted average expected term (in years) |
||||
Dividend yield |
||||
Weighted average fair value of warrants ( in €) |
Number of warrants outstanding |
Weighted- average exercise price (in Euros) |
Weighted- average remaining contractual term (in years) |
Aggregate intrinsic value (in thousands of Euros) |
|||||||||||||
Balance as of December 31, 2019 |
||||||||||||||||
Granted during the period |
— | — | — | — | ||||||||||||
Forfeited during the period |
— | — | — | — | ||||||||||||
Exercised during the period |
— | — | — | — | ||||||||||||
Expired during the period |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2020 |
— |
|||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Warrants exercisable as of December 31, 2020 |
— |
Number of warrants outstanding |
Weighted- average exercise price (in Euros) |
Weighted- average remaining contractual term (in years) |
Aggregate intrinsic value (in thousands of Euros) |
|||||||||||||
Balance as of December 31, 2020 |
— |
|||||||||||||||
Granted during the period |
— | — | ||||||||||||||
Forfeited during the period |
— | — | — | — | ||||||||||||
Exercised during the period |
— | — | — | — | ||||||||||||
Expired during the period |
( |
) | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2021 |
— |
|||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Warrants exercisable as of December 31, 2021 |
— |
Number of warrants outstanding |
Weighted- average exercise price in Euros |
Weighted- average remaining contractual term (in years) |
Aggregate intrinsic value in thousands of Euros |
|||||||||||||
Balance as of December 31, 2019 |
||||||||||||||||
Granted during the period |
— | — | — | — | ||||||||||||
Forfeited during the period |
— | — | — | — | ||||||||||||
Exercised during the period |
( |
) | — | — | ||||||||||||
Expired during the period |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2020 |
— |
|||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Warrants exercisable as of December 31, 2020 |
— |
Number of warrants outstanding |
Weighted- average exercise price in Euros |
Weighted- average remaining contractual term (in years) |
Aggregate intrinsic value in thousands of Euros |
|||||||||||||
Balance as of December 31, 2020 |
— |
|||||||||||||||
Granted during the period |
— | — | — | — | ||||||||||||
Forfeited during the period |
— | — | — | — | ||||||||||||
Exercised during the period |
( |
) | — | — | ||||||||||||
Expired during the period |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2021 |
— |
— |
— |
— |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Warrants exercisable as of December 31, 2021 |
— | — | — | — |
• | Before June 22, 2018 and after January 15, 2020, SO granted mainly vest over |
• | Between June 22, 2018 and January 15, 2020, SO may be exercised by the beneficiary once both of the following conditions have been met: |
• | Service condition: 25% upon the first anniversary of the issuance date and 12.5% every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions), and, |
• | Performance condition: approval of Viaskin ™ Peanut by the US Food and Drug Administration, |
Number of SO outstanding |
Weighted-average exercise price in Euros |
Weighted-average remaining contractual term (in years) |
Aggregate intrinsic value in thousands of Euros |
|||||||||||||
Balance as of December 31, 2019 |
||||||||||||||||
Granted during the period |
— | — | ||||||||||||||
Forfeited during the period |
( |
) | — | — | ||||||||||||
Exercised during the period |
( |
) | — | — | ||||||||||||
Expired during the period |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2020 |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Options exercisable as of December 31, 2020 |
— |
Number of SO outstanding |
Weighted-average exercise price in Euros |
Weighted-average remaining contractual term (in years) |
Aggregate intrinsic value in thousands of Euros |
|||||||||||||
Balance as of December 31, 2020 |
||||||||||||||||
Granted during the period |
— | — | ||||||||||||||
Forfeited during the period |
( |
) | — | — | ||||||||||||
Exercised during the period |
— | — | ||||||||||||||
Expired during the period |
— | — | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2021 |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Options exercisable as of December 31, 2021 |
— |
Assumptions per year ended, December 31, |
||||||||||||||||||||||||
Stock options per grant date |
Prior to 2017 |
2017 |
2018 |
2019 |
2020 |
2021 |
||||||||||||||||||
Weighted average shares price at grant date in € |
||||||||||||||||||||||||
Weighted average expected volatility |
% | % | % | % | % | % | ||||||||||||||||||
Weighted average risk-free interest rate |
% | ( |
)% | % | ( |
)% | ( |
)% | ( |
)% | ||||||||||||||
Weighted average expected term (in years) |
||||||||||||||||||||||||
Dividend yield |
||||||||||||||||||||||||
Weighted average fair value of stock-options (in €) |
• | Before May 31, 2019, the vesting of RSUs granted is subject to the expiration of the presence condition of one ( ™ Peanut, approval of Viaskin™ Peanut by the U.S. FDA, first sale of Viaskin™ Peanut in the United States); |
• | Between May 31, 2019 and November 23, 2020, the vesting of RSUs is subject either to the expiration of the presence condition of two (2) years only, or to the dual condition of expiration of the presence condition and achievement of the performance condition (date of approval of Viaskin ™ Peanut by the U.S. FDA); |
• | Since November 24, 2020, RSUs vest over |
Number of RSU outstanding |
Weighted average grant date fair value in Euros |
|||||||
Balance as of December 31, 2019 |
||||||||
Granted during the period |
||||||||
Forfeited during the period |
( |
) | ||||||
Released during the period |
( |
) | ||||||
Expired during the period |
||||||||
|
|
|
|
|||||
Balance as of December 31, 2020 |
||||||||
|
|
|
|
Number of RSU outstanding |
Weighted average grant date fair value in Euros |
|||||||
Balance as of December 31, 2020 |
||||||||
Granted during the period |
||||||||
Forfeited during the period |
( |
) | ||||||
Released during the period |
( |
) | ||||||
Expired during the period |
||||||||
|
|
|
|
|||||
Balance as of December 31, 2021 |
||||||||
|
|
|
|
December 31, |
||||||||||||
2021 |
2020 |
|||||||||||
Research and development |
|
SO |
|
( |
) | |||||||
|
RSU |
|
( |
) | ( |
) | ||||||
Sales and marketing |
|
SO |
|
( |
) | |||||||
|
RSU |
|
( |
) | ( |
) | ||||||
General and administrative |
|
SO |
|
( |
) | ( |
) | |||||
|
RSU |
|
( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Total share-based compensation (expense) income |
|
|
( |
) |
||||||||
|
|
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
Current contingencies |
||||||||
Non-current |
||||||||
|
|
|
|
|||||
Total contingencies |
||||||||
|
|
|
|
Pension retirement obligations |
Collaboration agreement—Loss at completion |
Other contingencies |
Total |
|||||||||||||
At January 1, 2020 |
|
|
|
|||||||||||||
Increases in liabilities |
— | |
|
|
||||||||||||
Used liabilities |
— | |
— | |
( |
) | |
( |
) | |||||||
Reversals of unused liabilities |
( |
) | |
— | |
— | |
( |
) | |||||||
Net interest related to employee benefits, and unwinding of discount |
|
— | |
— | |
|||||||||||
Actuarial gains and losses on defined-benefit plans |
( |
) | |
— | |
— | |
( |
) | |||||||
Currency translation effect |
|
|
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||
At December 31, 2020 |
|
|
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||
Of which Current |
— |
|
|
|
||||||||||||
Of which Non-current |
|
|
— |
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At January 1, 2021 |
||||||||||||||||
Increases in liabilities |
||||||||||||||||
Used liabilities |
— | — | ( |
) | ( |
) | ||||||||||
Reversals of unused liabilities |
— | — | ( |
) | ( |
) | ||||||||||
Net interest related to employee benefits, and unwinding of discount |
— | — | ||||||||||||||
Actuarial gains and losses on defined-benefit plans |
( |
) | — | — | ( |
) | ||||||||||
Currency translation effect |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
At December 31, 2021 |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Of which Current |
— |
|||||||||||||||
Of which Non-current |
— |
December 31, |
||||||||
2021 |
2020 |
|||||||
% Social security contributions |
% | % | ||||||
Salary increases |
% | % | ||||||
Discount rate—Iboxx Corporates AA 10+ |
% | % | ||||||
Expected staff turnover |
% |
% | ||||||
Estimated retirement age |
||||||||
Life table |
||||||||
Collective agreement |
December 31, |
||||||||
2021 |
2020 |
|||||||
Research tax credit |
||||||||
Other operating income |
( |
) | ||||||
|
|
|
|
|||||
Total |
||||||||
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
|
|
|
|
|
|
|
|
|
Research and Development expenses |
||||||||
Sales and Marketing expenses |
||||||||
General and Administrative expenses |
||||||||
Restructuring* |
||||||||
|
|
|
|
|||||
Total personnel expenses |
||||||||
|
|
|
|
* |
Restructuring personnel expenses excluding effect of accrual for the year ended December 31, 2020 and reversal for the year ended December 31, 2021. |
December 31, |
||||||||
2021 |
2020 |
|||||||
Wages and salaries |
||||||||
Social security contributions |
||||||||
Expenses for pension commitments |
||||||||
Employer contribution to bonus shares |
( |
) | ||||||
Share-based payments |
( |
) | ||||||
|
|
|
|
|||||
Total |
||||||||
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
(Loss) before taxes |
( |
) | ( |
) | ||||
Theoritical company tax rate |
% | % | ||||||
Nominal tax expense |
||||||||
|
|
|
|
|
|
|
|
|
Increase/decrease in tax expense arising from: |
||||||||
Research tax credit |
||||||||
Share-based compensation |
( |
) | ( |
) | ||||
Other permanent differences |
( |
) | ||||||
Non recognition of deferred tax assets mainly related to tax losses |
( |
) | ( |
) | ||||
Other differences |
( |
) | ( |
) | ||||
Effective tax expenses—current |
||||||||
Effective tax expenses—deferred |
— | — | ||||||
Effective tax rate |
( |
)% | ( |
)% |
December 31, |
||||||||
2021 |
2020 |
|||||||
Deferred tax assets: |
||||||||
Net operating loss carryforwards |
||||||||
Share-based compensation |
||||||||
Personnel-related accruals |
||||||||
Pension retirement obligations |
||||||||
Leases |
||||||||
Other |
||||||||
|
|
|
|
|||||
Total deferred tax assets |
||||||||
|
|
|
|
|||||
Less : Valuation allowance |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net deferred tax assets |
December 31, |
||||||||
2021 |
2020 |
|||||||
Short-term benefits |
||||||||
Post-employment benefits |
||||||||
Termination benefits |
||||||||
Share-based payments |
||||||||
|
|
|
|
|||||
Total |
December 31, |
||||||||
2021 |
2020 |
|||||||
Compensation |
||||||||
Pension obligations |
||||||||
|
|
|
|
|||||
Total |
December 31, |
||||||||
2021 |
2020 |
|||||||
Net loss |
( |
) | ( |
) | ||||
Weighted average number of ordinary shares |
||||||||
|
|
|
|
|||||
Basic and diluted net loss per share attributable to ordinary shareholders ($/share) |
( |
) |
( |
) | ||||
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
Non-employee warrants |
||||||||
Employee warrants |
||||||||
Stock-options |
||||||||
Restricted stock units |