DBV Technologies (DBVT) risk factors, FY2024 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future
2. 02The Company has incurred operating losses and negative cash flows from operations since inception
3. 03We 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
4. 04Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $32.5 million as of December 31, 2024 will be sufficient to fund our operations into April 2025
5. 05If we cannot conduct necessary operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected
6. 06We are limited in our ability to raise additional share capital, which may make it difficult for us to raise capital to fund our operations
7. 07We 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
8. 08If we do not obtain the capital necessary to fund our operations, we will be unable to successfully commercialize, develop or pursue regulatory approval for our biopharmaceutical products
9. 09The requirements of being a U.S. public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members

Risks Related to Product Development, Regulatory Approval and Commercialization

1. 10We 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
2. 11In many of clinical trials, we utilize an oral food challenge procedure intentionally designed to trigger an allergic reaction, which could be severe or life-threatening
3. 12Delays, suspensions and terminations in our clinical trials could result in increased costs to us and delay or prevent our ability to generate revenues
4. 13For example, we announced in September 2022 that FDA had imposed a partial clinical hold on the VITESSE trial, which was lifted in December 2022, resulting in a delay in initiation and conduct of the VITESSE trial
5. 14If our product candidates are not approved by the FDA, or comparable foreign regulatory authorities, we will be unable to commercialize them in the United States or in other countries
6. 15A Fast Track designation by the FDA, or equivalent foreign programs, may not actually lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive regulatory approval
7. 16In order to market and sell our product candidates in the European Union and many other jurisdictions, we, and our collaborators, must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and may involve additional testing
8. 17Even if we, or our collaborators, obtain regulatory 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
9. 18If 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
10. 19Access 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
11. 20Relying on third-party manufacturers may result in delays in our clinical development or commercialization efforts
12. 21Our Viaskin product candidates may not be able to be manufactured profitably on a large enough scale to support commercialization
13. 22We, or the third parties upon whom we depend, may be adversely affected by earthquakes, other natural disasters or outbreaks of contagious diseases and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
14. 23We 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
15. 24Our product candidates are regulated as biological products, or biologics, which may subject them to competition sooner than anticipated
16. 25Even if any of our product candidates are commercialized, they may not be accepted by physicians, patients, or the medical community in general. Even if we, or our collaborators, are able to commercialize our product candidates, the products may become subject to market conditions that could harm our business
17. 26We face substantial competition from companies with considerably more resources and experience than we have, which may result in others discovering, developing, receiving approval for, or commercializing products before or more successfully than us
18. 27Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-containment initiatives, may negatively impact our ability to generate revenues if we obtain regulatory approval to market a product
19. 28Guidelines and recommendations published by various organizations may impact the use or reimbursement of Viaskin Peanut, if approved
20. 29Our 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 regulatory approval, if any
21. 30Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
22. 31We are subject to healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, integrity obligations, exclusion from government healthcare programs, individual imprisonment, contractual damages, reputational harm and diminished profits and future earnings, among other consequences
23. 32result 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
24. 33It is currently unclear to what extent the UK will seek to align its regulations with the EU in the future. The UK regulatory framework in relation to clinical trials is derived from existing EU legislation (as implemented into UK law, through secondary legislation)
25. 34The FDA and other comparable foreign regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found to have improperly promoted off-label uses, we may become subject to significant liability
26. 35Our product development programs may require substantial financial resources and may ultimately be unsuccessful
27. 36If 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
28. 37Thus, collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all
29. 38Our ability to compete may decline if we do not adequately protect our proprietary rights
30. 39Biopharmaceutical patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position
31. 40Developments in patent law could have a negative impact on our business
32. 41If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
33. 42We 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
34. 43Third parties may assert ownership or commercial rights to inventions we develop
35. 44Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets
36. 45A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business
37. 46Either we or these individuals may be subject to allegations of trade secret misappropriation or other similar claims as a result of prior affiliations
38. 47Our success will depend in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties. We cannot assure you that our business, products and methods do not or will not infringe the patents or other intellectual property rights of third parties
39. 48Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court

Risks Related to Our Organization, Structure and Operations

1. 49We depend on key personnel and attracting qualified management personnel and our business could be harmed if we lose key personnel and cannot attract new personnel
2. 50Our employees may engage in misconduct or other improper activities, including violating applicable regulatory standards and requirements or engaging in insider trading, which could significantly harm our business
3. 51Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our product candidates
4. 52We may incur significant costs from class action litigation
5. 53We may be subject to legal or administrative proceedings and litigation other than product liability lawsuits which may be costly to defend and could materially harm our business, financial condition and operations
6. 54Our failure to maintain certain tax benefits applicable to French technology companies may adversely affect our Operating Income
7. 55We may be exposed to significant foreign exchange risk. Exchange rate fluctuations may adversely affect the foreign currency value of our ADSs
8. 56We may use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly
9. 57activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations that govern the processing of personal data by us and on our behalf
10. 58We may acquire businesses or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions
11. 59We 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

Risks Related to Ownership of Our Ordinary Shares and ADSs

1. 60The market price for our ordinary shares and ADSs may be volatile or may decline regardless of our operating performance
2. 61Share ownership is concentrated in the hands of our principal shareholders and management, who will continue to be able to exercise a direct or indirect controlling influence on us
3. 62If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the price of the ADSs and trading volume could decline
4. 63If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our ADSs could be delisted
5. 64We have never declared or paid any cash dividends on our ordinary shares and do not currently intend to do so for the foreseeable future. We currently intend to invest our future earnings, if any, to fund our growth
6. 65Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs
7. 66The dual listing of our ordinary shares and our ADSs may adversely affect the liquidity and value of the ADSs
8. 67Our by-laws and French corporate law contain provisions that may delay or discourage a takeover attempt
9. 68You may not be able to exercise your right to vote the ordinary shares underlying your ADSs
10. 69Your right as a holder of ADSs to participate in any future preferential subscription rights or to elect to receive dividends in shares may be limited, which may cause dilution to your holdings
11. 70You may be subject to limitations on the transfer of your ADSs and the withdrawal of the underlying ordinary shares
12. 71The biotechnology industry has been included in the list of critical technologies subject to foreign investment control procedure in France, which may limit the ability to certain non-French investors to participate in this or any other offering of our securities
13. 72U.S. Investors may have difficulty enforcing civil liabilities against our company and directors and senior management
14. 73The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States
15. 74We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our ADSs less attractive to investors
16. 75U.S. holders may suffer adverse tax consequences if we are characterized as a passive foreign investment company