Canlı Haberler • 15h
DBV Technologies Reports Q1 Loss as Viaskin Peanut Patch Nears 2026 FDA Submissions DBV Technologies reported a Q1 2026 net loss of $47.6 million as it increased research, development, and commercialization spending for its Viaskin Peanut Patch.
The company is preparing two Biologics License Application filings in 2026 for children aged 4 to 7 years and toddlers aged 1 to 3 years, following positive Phase 3 VITESSE trial results.
DBV also plans to start a Phase 2 THRIVE study in peanut-allergic infants aged 6 to 12 months and reported cash reserves of $229 million at 31 March 2026, which it expects to fund operations into Q2 2027 and support U.S. commercial build-out.
The key story is a company in heavy investment mode, with wider losses tied to pushing its lead peanut allergy patch through late-stage development and toward potential regulatory filings in 2026.
The main trade-off for investors is higher short-term cash burn versus the possibility that upcoming regulatory and clinical milestones materially change DBV’s risk profile if they do not progress as planned. Major Estimate Revision • May 11
Consensus revenue estimates decrease by 14% The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from US$4.45m to US$3.82m. EPS estimate unchanged from -US$0.50 per share at last update. Biotechs industry in France expected to see average net income growth of 20% next year. Consensus price target broadly unchanged at €3.80. Share price was steady at €3.40 over the past week. Reported Earnings • May 05
First quarter 2026 earnings released: US$0.11 loss per share (vs US$0.26 loss in 1Q 2025) First quarter 2026 results: US$0.11 loss per share. Net loss: US$47.6m (loss widened 76% from 1Q 2025). Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 54% growth forecast for the Biotechs industry in France. Duyuru • May 01
DBV Technologies S.A., Annual General Meeting, Jun 03, 2026 DBV Technologies S.A., Annual General Meeting, Jun 03, 2026. Location: 107 avenue de la republique, chatillon France Reported Earnings • Mar 29
Full year 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2025 results: US$1.05 loss per share. Net loss: US$146.9m (loss widened 29% from FY 2024). Revenue missed analyst estimates by 11%. Earnings per share (EPS) exceeded analyst estimates by 24%. Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 49% growth forecast for the Biotechs industry in France. Breakeven Date Change • Mar 29
Forecast to breakeven in 2028 The 5 analysts covering DBV Technologies expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 20% per year to 2027. The company is expected to make a profit of US$86.5m in 2028. Average annual earnings growth of 61% is required to achieve expected profit on schedule. Duyuru • Mar 02
Dbv Technologies Highlights Additional Data from Successful Phase 3 Vitesse Study At the Aaaai 2026 Annual Meeting DBV Technologies announced that the company shared additional positive data from the successful Phase 3 VITESSE clinical trial as an oral presentation at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2026 Annual Meeting, in Philadelphia, PA. VITESSE, the food allergy immunotherapy trial to date, is a Phase 3 study assessing DBV's VIASKIN®? Peanut Patch for the treatment of peanut-allergic children aged 4 to 7 years. The VITESSE study met its primary endpoint whereby VIASKIN®?Peanut demonstrated a statistically significant treatment effect (pp. The increases in eliciting dose seen are clinically meaningful and may reflect a reduced risk of an allergic reaction. Conversely, nearly four times as many children on placebo saw their eliciting dose decrease, becoming more sensitized over the twelve-month period. These results not only support the VIASKIN®? peanut Patch as a potential treatment option for peanut-allergic children, if approved, but also reinforce the importance of prioritizing a proactive treatment for this specific patient population. Price Target Changed • Dec 22
Price target increased by 116% to €3.29 Up from €1.52, the current price target is an average from 2 analysts. New target price is approximately in line with last closing price of €3.43. Stock is up 446% over the past year. The company is forecast to post a net loss per share of US$1.05 next year compared to a net loss per share of US$1.17 last year. Major Estimate Revision • Dec 17
Consensus revenue estimates decrease by 10% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$7.00m to US$6.26m. EPS estimate unchanged from -US$1.05 per share at last update. Biotechs industry in France expected to see average net income growth of 34% next year. Consensus price target of €1.56 unchanged from last update. Share price rose 11% to €3.68 over the past week. Major Estimate Revision • Nov 07
Consensus revenue estimates decrease by 14%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$7.78m to US$6.69m. EPS estimate increased from -US$1.27 to -US$1.05 per share. Biotechs industry in France expected to see average net income growth of 25% next year. Consensus price target up from €1.52 to €1.56. Share price fell 5.5% to €2.48 over the past week. Duyuru • Nov 04
DBV Technologies Appoints Industry Leader Kevin Trapp as Chief Commercial, Effective November 3, 2025 DBV Technologies announced the appointment of Kevin Trapp as Chief Commercial Officer, effective immediately. In his role, Mr. Trapp will report directly to Daniel Tasse, Chief Executive Officer, as a member of the executive team and will lead all aspects of global commercial strategy and execution for the Viaskin(R) Peanut patch. DBV expects to submit a Biologics License Application (BLA) submission for children 4-7 years-old living with peanut allergy in the first half of 2026, followed by an anticipated BLA submission for 1-3 year-olds in the second half of the year. Kevin Trapp is an accomplished commercial executive with more than 30 years of experience in the biopharmaceutical industry. Before rejoining DBV, Kevin served as a consultant to the Company in his most recent role as Managing Director at Biotech Value Advisors (BVA) where he advised biotechnology boards of directors and executive leadership with product strategy, launch planning, and business evaluation. He built his career at Bristol-Myers Squibb (BMS), where he held roles of increasing responsibility across finance, sales, marketing, and general management. During his time at BMS, he managed a ~$4 billion U.S. specialty and primary care portfolio and was a key stakeholder in the planning and subsequent launches of more than 10 products and indications - including Abilify(R), Atripla(R), Reyataz(R), Orencia(R), and Daklinza(R). Mr. Trapp earned a bachelor's degree from the University of Connecticut School of Business and completed the General Management Program from the European Centre for Executive Development (CEDEP) at INSEAD. New Risk • Oct 30
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$98m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$98m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (42% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$81m net loss in 3 years). Duyuru • Sep 19
DBV Technologies Announces Resignation of Daniel Soland as a Member of its Board of Directors, Effective September 18, 2025 DBV Technologies announced the resignation of Daniel Soland, as a member of its Board of Directors, effective September 18, 2025. Duyuru • Sep 06
DBV Technologies S.A. has filed a Follow-on Equity Offering in the amount of $150 million. DBV Technologies S.A. has filed a Follow-on Equity Offering in the amount of $150 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Transaction Features: At the Market Offering Major Estimate Revision • Aug 13
Consensus EPS estimates upgraded to US$0.86 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$1.17 to -US$0.86 per share. Revenue forecast steady at US$4.03m. Biotechs industry in France expected to see average net income growth of 7.2% next year. Consensus price target of €1.52 unchanged from last update. Share price was steady at €1.69 over the past week. Major Estimate Revision • Aug 05
Consensus revenue estimates increase by 33% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$2.98m to US$3.98m. EPS estimate unchanged from -US$1.17 at last update. Biotechs industry in France expected to see average net income growth of 7.2% next year. Consensus price target of €1.52 unchanged from last update. Share price fell 4.6% to €1.63 over the past week. Reported Earnings • Jul 30
Second quarter 2025 earnings released: US$0.31 loss per share (vs US$0.34 loss in 2Q 2024) Second quarter 2025 results: US$0.31 loss per share. Net loss: US$41.9m (loss widened 26% from 2Q 2024). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in France. Duyuru • Jul 23
DBV Technologies S.A. Announces Executive Changes DBV Technologies S.A. announced the appointment of James Briggs as its Chief Human Resources Officer, succeeding Caroline Daniere. An experienced human capital executive, James will lead key initiatives as DBV transitions from a development-stage biotechnology company to a potential commercial organization. Mr. Briggs will report directly to Daniel Tassé, Chief Executive Officer, and serve as a member of the Executive Committee. Most recently, Mr. Briggs served as Partner at East Bay Human Capital, a human resources consulting firm specializing in human capital strategy, change management, and organizational design. Previously, he held several executive roles, including Chief Executive Officer at MNG Health, where he led the successful turnaround and sale of the healthcare technology company. He also served as Chief Human Resources Officer at multiple organizations, including Ciox Health and Ikaria Inc. Mr. Briggs holds a Master's degree in Human Relations and a Bachelor's degree in Communications from the University of Illinois at Urbana-Champaign. He is a certified Senior Professional in Human Resources (SPHR) and a Six Sigma Green Belt. Price Target Changed • Jul 01
Price target decreased by 38% to €1.52 Down from €2.46, the current price target is an average from 2 analysts. New target price is approximately in line with last closing price of €1.56. Stock is up 96% over the past year. The company is forecast to post a net loss per share of US$1.17 next year compared to a net loss per share of US$1.17 last year. Board Change • Jul 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 4 highly experienced directors. Independent Director Tim Morris was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Duyuru • Jun 26
DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 - 3 Years Old DBV Technologies provided an update on the progress on the Company's COMFORT Toddlers supplemental safety study using the Viaskin®? Peanut patch 250 mg in peanut-allergic children ages 1 - 3 years old. COMFORT Toddlers will enroll approximately 480 subjects at approximately 80 - 90 study centers across the U.S., Canada, Australia, UK and Europe. COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) safety study designed to supplement the safety and efficacy data from the completed Phase 3 EPITOPE study in the same population. The study duration will be six months followed by an optional 18-month open-label treatment phase, to generate up to 24 or 18 months of active treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. Duyuru • May 06
DBV Technologies S.A., Annual General Meeting, Jun 11, 2025 DBV Technologies S.A., Annual General Meeting, Jun 11, 2025. Location: 107 avenue de la republique 92320 chatillon, France Duyuru • Apr 01
DBV Technologies S.A. announced delayed annual 10-K filing On 03/31/2025, DBV Technologies S.A. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Reported Earnings • Mar 24
Full year 2024 earnings released: US$1.17 loss per share (vs US$0.77 loss in FY 2023) Full year 2024 results: US$1.17 loss per share (further deteriorated from US$0.77 loss in FY 2023). Net loss: US$113.9m (loss widened 57% from FY 2023). Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 27% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 34% per year, which means it is significantly lagging earnings. New Risk • Jan 03
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 6.5% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$109m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$115m net loss in 3 years). Shareholders have been diluted in the past year (6.5% increase in shares outstanding). Market cap is less than US$100m (€67.0m market cap, or US$68.9m). Duyuru • Dec 17
DBV Technologies Regains Compliance with Nasdaq Listing Rule 5550(a)(2) On December 13, 2024, DBV Technologies S.A. (the Company") received a letter from the Listing Qualifications Staff (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that the Staff has determined that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2). The Staff determined that for 10 consecutive business days, from November 29, 2024 to December 12, 2024, the closing bid price of the Company's American Depositary Shares has been at $1.00 per share or greater. Duyuru • Nov 12
DBV Technologies Announces Plan to Implement ADS Ratio Change to Regain Compliance DBV Technologies S.A. announced plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value €0.10 (ten cents) per share, from the current ADS Ratio of one (1) ADS to one (1) ordinary share to a new ADS Ratio of one (1) ADS to five (5) ordinary shares (the “ADS Ratio Change”). The Company anticipates that the ADS Ratio Change will be effective on or about November 29, 2024 (the “Effective Date”). For the Company’s ADS holders, the change in the ADS Ratio will have the same effect as a one-for-five reverse ADS split and is intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement. Reported Earnings • Nov 08
Third quarter 2024 earnings released: US$0.32 loss per share (vs US$0.17 loss in 3Q 2023) Third quarter 2024 results: US$0.32 loss per share (further deteriorated from US$0.17 loss in 3Q 2023). Revenue: US$1.07m (down 55% from 3Q 2023). Net loss: US$30.4m (loss widened 82% from 3Q 2023). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 31% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has fallen by 50% per year, which means it is significantly lagging earnings. New Risk • Oct 23
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$105m free cash flow). Earnings are forecast to decline by an average of 5.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$117m net loss in 3 years). Market cap is less than US$100m (€69.6m market cap, or US$75.0m). Duyuru • Oct 23
Dbv Technologies Announces Positive Regulatory Updates for the Viaskin Peanut Patch in the United States and Europe DBV Technologies announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV has agreed to guidance provided by the U.S. Food and Drug Administration on a pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old and has also received scientific advice from the EMA on a 1 – 7 year-old indication in Europe. DBV intends to formalize the Accelerated Approval guidance provided by the FDA via submission of a meeting request. Viaskin Peanut Patch in Toddlers 1 – 3 Years. Accelerated Approval Pathway, FDA guidance for Accelerated Approval include three qualifying criteria: 1) that the product treats a serious condition, 2) that the product candidate generally provides a meaningful advantage over available therapies, and 3) that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. FDA confirmed that DBV has met criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which DBV has agreed to in informal discussions with the FDA. DBV intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. DBV expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved. COMFORT Toddlers DBV is pleased to have aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The company anticipates enrolling approximately 300 - 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 year-olds under the Accelerated Approval program is anticipated to be supported by: i. Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and ii. Additional safety data generated in COMFORT Toddlers supplemental safety study to be initiated in Second Quarter 2025. DBV and FDA are in general agreement that the confirmatory study will need to demonstrate the effectiveness of the Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. DBV will prioritize initiation of the COMFORT Toddlers safety study to enable the BLA submission. DBV and the FDA have been engaged in ongoing dialogue regarding the COMFORT Toddlers supplemental safety study in 1 – 3 year-olds with a peanut allergy. The focus of continued exchanges has been on patch adhesion, specifically: The hierarchy of an adhesion assessment within the COMFORT Toddlers study (FDA requesting that it be a study objective vs. exploratory assessment); The sufficiency of adhesion data collected during the EPITOPE study to fully characterize daily patch adhesion duration (wear time) given the EPITOPE adhesion data collection methodology, and, conversely, the collection methodology required to generate sufficient adhesion data to inform the Viaskin label in future studies; and the clinical relevance and regulatory use of adhesion data collected in a study that does not include an efficacy assessment. Viaskin Peanut Patch in Children 4 – 7, In September 2024, DBV announced that patient screening had been completed for the Phase 3 efficacy trial of the Viaskin Peanut patch in peanut allergic children ages 4 – 7 years-old (VITESSE). A total of 654 subjects were enrolled, and DBV anticipates topline data in the fourth quarter of 2025. The COMFORT Children safety study is expected to be initiated in the second quarter of 2025. This study plans to enroll approximately 250 subjects to raise the total number of 4 – 7 year-olds on active treatment across the development program to approximately 600, consistent with prior FDA guidance. These two studies will constitute the core studies for a BLA submission in 4 – 7 year-olds. Price Target Changed • Sep 04
Price target decreased by 48% to €2.45 Down from €4.73, the current price target is an average from 2 analysts. New target price is 195% above last closing price of €0.83. Stock is down 74% over the past year. The company is forecast to post a net loss per share of US$1.06 next year compared to a net loss per share of US$0.76 last year. Major Estimate Revision • Aug 06
Consensus revenue estimates decrease by 18% The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$6.49m to US$5.33m. EPS estimate unchanged from -US$1.06 per share at last update. Biotechs industry in France expected to see average net income decline 8.9% next year. Consensus price target of €4.32 unchanged from last update. Share price fell 9.8% to €0.86 over the past week. Reported Earnings • Jul 31
Second quarter 2024 earnings released: US$0.34 loss per share (vs US$0.26 loss in 2Q 2023) Second quarter 2024 results: US$0.34 loss per share (further deteriorated from US$0.26 loss in 2Q 2023). Revenue: US$1.16m (down 49% from 2Q 2023). Net loss: US$33.1m (loss widened 37% from 2Q 2023). Revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 34% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 36% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. Duyuru • Jul 29
DBV Technologies S.A. to Report Q2, 2024 Results on Jul 30, 2024 DBV Technologies S.A. announced that they will report Q2, 2024 results on Jul 30, 2024 New Risk • Jul 23
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 6.6% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$95m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$97m net loss in 3 years). Share price has been volatile over the past 3 months (6.6% average weekly change). Market cap is less than US$100m (€86.1m market cap, or US$93.5m). Duyuru • Jun 20
DBV Technologies Provides Non-Compliance Update Related to Nasdaq Listing Rule 5550(a)(2) & 5810(c)(3)(A) On December 22, 2023, DBV Technologies S.A. (the Company) reported that it had received a letter from the Listing Qualifications Department of the Nasdaq Stock Market on December 20, 2023 regarding the Company’s failure to comply with Nasdaq Continued Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. A failure to comply with Rule 5550(a)(2) exists when listed securities fail to maintain a closing bid price of at least $1.00 per share for 30 consecutive business days. Under Rule 5810(c)(3)(A), the Company automatically was provided a period of 180 calendar days, until June 17, 2024, to regain compliance. On June 18, 2024, the Company was notified by the Listing Qualifications Department that Nasdaq granted the Company’s request to transfer the listing of its American Depositary Shares (“ADSs”) from The Nasdaq Global Select Market tier to The Nasdaq Capital Market tier, and that Nasdaq granted the Company’s request for a second 180-calendar day period, or until December 16, 2024 (the “Second Compliance Period”), to regain compliance with the $1.00 bid price requirement, as set in Rule 5550(a)(2). To regain compliance with such minimum price requirement, the Company must evidence a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. The transfer of the listing of the ADSs from The Nasdaq Global Select Market tier to The Nasdaq Capital Market tier will take effect with the open of business on June 20, 2024. The transfer is not expected to impact trading in the ADSs, which will continue to trade on Nasdaq under the symbol “DBVT.” In the event that the Company is not able to cure the bid price deficiency during the Second Compliance Period, Nasdaq will provide written notice that the ADSs will be delisted; however, the Company may request a hearing before the Nasdaq Hearings Panel (the “Panel”), which request, if timely made, would stay any further suspension or delisting action by Nasdaq pending the conclusion of the hearing process and expiration of any extension that may be granted by the Panel. Although the Company will use all reasonable efforts to achieve compliance with Rule 5550(a)(2), there can be no assurance that the Company will be able to regain compliance with that rule or will otherwise be in compliance with other Nasdaq listing criteria. Major Estimate Revision • May 14
Consensus EPS estimates upgraded to US$0.74 loss, revenue downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$7.02m to US$6.85m. 2024 losses expected to reduce from -US$0.825 to -US$0.74 per share. Biotechs industry in France expected to see average net income growth of 7.7% next year. Consensus price target broadly unchanged at €4.73. Share price was steady at €1.21 over the past week. Price Target Changed • May 09
Price target increased by 36% to €6.50 Up from €4.78, the current price target is an average from 2 analysts. New target price is 440% above last closing price of €1.20. Stock is down 63% over the past year. The company is forecast to post a net loss per share of US$0.74 next year compared to a net loss per share of US$0.76 last year. Reported Earnings • May 08
First quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2024 results: US$0.28 loss per share (further deteriorated from US$0.22 loss in 1Q 2023). Revenue: US$1.41m (down 36% from 1Q 2023). Net loss: US$27.3m (loss widened 33% from 1Q 2023). Revenue missed analyst estimates by 20%. Earnings per share (EPS) exceeded analyst estimates by 21%. Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 38% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 40% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. New Risk • May 08
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 14% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$80m free cash flow). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$106m net loss in 3 years). Share price has been volatile over the past 3 months (6.8% average weekly change). Shareholders have been diluted in the past year (2.4% increase in shares outstanding). Breakeven Date Change • May 08
No longer forecast to breakeven The 2 analysts covering DBV Technologies no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$127.4m in 2026. New consensus forecast suggests the company will make a loss of US$5.71m in 2026. Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Independent Director Tim Morris was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Duyuru • Mar 25
DBV Technologies S.A., Annual General Meeting, May 16, 2024 DBV Technologies S.A., Annual General Meeting, May 16, 2024. New Risk • Mar 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$73m Forecast net loss in 3 years: US$13m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$80m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Share price has been volatile over the past 3 months (7.8% average weekly change). Shareholders have been diluted in the past year (2.3% increase in shares outstanding). Breakeven Date Change • Mar 14
No longer forecast to breakeven The 3 analysts covering DBV Technologies no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$128.7m in 2026. New consensus forecast suggests the company will make a loss of US$119.6m in 2026. Reported Earnings • Mar 10
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: US$0.77 loss per share (improved from US$1.24 loss in FY 2022). Revenue: US$15.7m (up 225% from FY 2022). Net loss: US$72.7m (loss narrowed 25% from FY 2022). Revenue exceeded analyst estimates by 85%. Earnings per share (EPS) also surpassed analyst estimates by 21%. Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 35% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 42% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings. Price Target Changed • Mar 08
Price target decreased by 17% to €4.43 Down from €5.30, the current price target is an average from 4 analysts. New target price is 212% above last closing price of €1.42. Stock is down 55% over the past year. New Risk • Mar 08
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$90m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$90m free cash flow). Minor Risks Share price has been volatile over the past 3 months (8.1% average weekly change). Shareholders have been diluted in the past year (2.4% increase in shares outstanding). Duyuru • Mar 05
DBV Technologies S.A. to Report Fiscal Year 2023 Results on Mar 07, 2024 DBV Technologies S.A. announced that they will report fiscal year 2023 results on Mar 07, 2024 Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 3 analysts covering DBV Technologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$124.0m in 2026. Average annual earnings growth of 48% is required to achieve expected profit on schedule. Duyuru • Dec 22
DBV Technologies Receives a Letter from the Listing Qualifications Staff of the Nasdaq Stock Market On December 20, 2023, DBV Technologies S.A. received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC notifying the Company that for the last 30 consecutive business days, the bid price of the Company's American Depositary Shares had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). The notification received has no immediate effect on the listing of the Company's ADSs on the Nasdaq Stock Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until June 17, 2024, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company's ADSs must be at least $1.00 per share for a minimum of ten consecutive business days before the Compliance Date. If the Company's ADSs do not achieve compliance by the Compliance Date, the Company may be eligible for an additional 180-day period to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. The Company intends to actively monitor the closing bid price of its ADSs between now and the Compliance Date and will evaluate available options to resolve the deficiency and regain compliance with the minimum bid price rule. Duyuru • Nov 03
DBV Technologies S.A. to Present New Data at ACAAI 2023 DBV Technologies S.A. announced that new data on the use of Viaskin™ Peanut (DBV712) 250 µg in peanut-allergic toddlers will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, which is being held November 9 – November 13, 2023, in Anaheim, CA. A late-breaking oral abstract has been accepted by the ACAAI and will be presented on the interim 12-month results from the ongoing Phase 3 open-label extension to the EPITOPE trial (EPOPEX) trial of Viaskin™ Peanut in peanut-allergic toddlers. The meeting will also feature a “Product Theater” on Individualizing Peanut Allergy Management: A Case-based Panel Discussion. Drs. Douglas Mack, David Stukus, and Julie Wang will engage in a discussion around the factors influencing peanut allergy management, such as use of food challenges and effects of comorbidities, using various patient scenarios. Viaskin Peanut is the Company’s lead product candidate designed to reduce the risk of allergic reactions due to accidental exposure to peanuts. An investigational, non-invasive, once-daily epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to re-educate the immune system. The safety and efficacy of Viaskin Peanut have not yet been established by the U.S. Food and Drug Administration or the European Medicines Agency. Reported Earnings • Nov 02
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: US$0.17 loss per share (improved from US$0.18 loss in 3Q 2022). Net loss: US$16.7m (loss narrowed 3.2% from 3Q 2022). Revenue exceeded analyst estimates by 79%. Earnings per share (EPS) also surpassed analyst estimates by 41%. Revenue is forecast to grow 9.2% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 41% per year but the company’s share price has fallen by 20% per year, which means it is significantly lagging earnings. Major Estimate Revision • Nov 02
Consensus revenue estimates increase by 29% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$6.30m to US$8.11m. EPS estimate unchanged from -US$0.99 at last update. Biotechs industry in France expected to see average net income growth of 26% next year. Consensus price target of €6.18 unchanged from last update. Share price fell 5.1% to €2.02 over the past week. Duyuru • Oct 28
DBV Technologies S.A. to Report Q3, 2023 Results on Oct 31, 2023 DBV Technologies S.A. announced that they will report Q3, 2023 results on Oct 31, 2023 Duyuru • Oct 18
DBV Technologies S.A. Announces Executive Changes On October 16, 2023, DBV Technologies S.A. announced the appointment of Virginie Boucinha as the Company’s Chief Financial Officer and principal accounting officer, effective as of November 6, 2023. In addition, the Company announced that Sébastien Robitaille, who currently serves as the Company’s Chief Financial Officer, will separate employment with the Company effective November 17, 2023 to pursue other opportunities. Ms. Boucinha, 53, has served as Group Performance Director of the Pierre Fabre Group, a pharmaceutical company, since February 2022. Prior to Pierre Fabre Group, Ms. Boucinha spent over fifteen years through July 2021 with Sanofi, a pharmaceutical manufacturing company, where she served in progressively senior finance and operational leadership roles. In her most recent roles, she was the Global Transformation Office Head from May 2018 to July 2021, where she was a member of the senior leadership team responsible for company structural organization and governance redesign and implementation, and Chief of Staff to the CEO from July 2015 to March 2018, where she handled the chief executive officer and executive committee agenda and coordination, the chief executive officer briefing and strategic projects. Ms. Boucinha is a graduate of Ecole Superieure de Gestion where she obtained a Master of Business Administration. Duyuru • Oct 17
DBV Technologies S.A. Appoints Virginie Boucinha as Principal Accounting Officer, Effective as of November 6, 2023 On October 16, 2023, DBV Technologies S.A. announced the appointment of Virginie Boucinha as the Company’s Chief Financial Officer and principal accounting officer, effective as of November 6, 2023. In addition, the Company announced that Sébastien Robitaille, who currently serves as the Company’s Chief Financial Officer, will separate employment with the Company effective November 17, 2023 to pursue other opportunities. Ms. Boucinha, 53, has served as Group Performance Director of the Pierre Fabre Group, a pharmaceutical company, since February 2022. Prior to Pierre Fabre Group, Ms. Boucinha spent over fifteen years through July 2021 with Sanofi, a pharmaceutical manufacturing company, where she served in progressively senior finance and operational leadership roles. In her most recent roles, she was the Global Transformation Office Head from May 2018 to July 2021, where she was a member of the senior leadership team responsible for company structural organization and governance redesign and implementation, and Chief of Staff to the CEO from July 2015 to March 2018, where she handled the chief executive officer and executive committee agenda and coordination, the chief executive officer briefing and strategic projects. Ms. Boucinha is a graduate of Ecole Superieure de Gestion where she obtained a Master of Business Administration. Duyuru • Aug 02
Dbv Technologies S.A. Receives Feedback from FDA on Design Elements for Viaskin Peanut Safety Studies DBV Technologies announced the receipt of Written Responses from the FDA on key study design elements for the COMFORT (Characterization of the Optimal Management of FOod Allergy Relief and Treatment) Toddlers and COMFORT Children supplemental safety studies in 1 – 3-year-olds and 4 – 7-year-olds, respectively, with a peanut allergy. The Company also reported financial results for the second quarter and the first half of 2023. The quarterly and half-year financial statements were approved by the Board of Directors on July 28, 2023. Viaskin™ Peanut in 1 – 3-year-olds (original square patch) and Viaskin™ Peanut in 4 – 7-year-olds (modified circular patch) are separate product candidates with independent clinical and regulatory paths supporting two distinct Biologics License Applications (BLAs). DBV received Type C Meeting Written Responses from the FDA on the two supplemental safety studies, known as COMFORT. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 – 3-years and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 – 7-years and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. The FDA agreed with a 6-month study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. Both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE. Neither the COMFORT Toddlers study nor the COMFORT Children study will require an oral food challenge for participation. The feedback received is consistent with FDA’s position on COMFORT Children in 4 – 7-year-olds, as previously announced in December 2022. Both COMFORT studies aim to bring the total number of subjects on active treatment to approximately 600 participants in each age group, when added to their respective Phase 3 pivotal efficacy studies (i.e., EPITOPE and VITESSE). Reported Earnings • Aug 01
Second quarter 2023 earnings released: US$0.26 loss per share (vs US$0.35 loss in 2Q 2022) Second quarter 2023 results: US$0.26 loss per share. Net loss: US$24.2m (loss widened 5.2% from 2Q 2022). Revenue is expected to decline by 2.5% p.a. on average during the next 3 years, while revenues in the Biotechs industry in France are expected to grow by 25%. Duyuru • Jul 26
DBV Technologies S.A. to Report First Half, 2023 Results on Jul 31, 2023 DBV Technologies S.A. announced that they will report first half, 2023 results on Jul 31, 2023 New Risk • Jul 26
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.4% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$34m net loss in 3 years). Share price has been volatile over the past 3 months (9.2% average weekly change). Shareholders have been diluted in the past year (3.4% increase in shares outstanding). Revenue is less than US$5m (US$4.5m revenue). Major Estimate Revision • May 11
Consensus revenue estimates increase by 18% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$4.74m to US$5.61m. Forecast losses expected to reduce from -US$1.08 to -US$0.965 per share. Biotechs industry in France expected to see average net income decline 3.7% next year. Consensus price target of €5.66 unchanged from last update. Share price rose 14% to €3.29 over the past week. Reported Earnings • May 07
First quarter 2023 earnings: EPS and revenues exceed analyst expectations First quarter 2023 results: US$0.22 loss per share. Net loss: US$20.6m (loss widened 23% from 1Q 2022). Revenue exceeded analyst estimates by 90%. Earnings per share (EPS) also surpassed analyst estimates by 17%. Revenue is expected to decline by 2.2% p.a. on average during the next 3 years, while revenues in the Biotechs industry in France are expected to grow by 22%. Major Estimate Revision • Mar 09
Consensus revenue estimates decrease by 26% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$6.49m to US$4.79m. EPS estimate unchanged from -US$1.12 per share at last update. Biotechs industry in France expected to see average net income decline 11% next year. Consensus price target of €5.64 unchanged from last update. Share price rose 17% to €3.29 over the past week. Breakeven Date Change • Mar 03 The 3 analysts covering DBV Technologies previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 0.8% per year to 2024. The company is expected to make a profit of US$24.8m in 2025. Average annual earnings growth of 54% is required to achieve expected profit on schedule.
Reported Earnings • Mar 03
Full year 2022 earnings: EPS and revenues miss analyst expectations Full year 2022 results: US$1.24 loss per share (improved from US$1.78 loss in FY 2021). Net loss: US$96.3m (loss narrowed 1.6% from FY 2021). Revenue missed analyst estimates by 36%. Earnings per share (EPS) also missed analyst estimates by 34%. Revenue is forecast to grow 23% p.a. on average during the next 2 years, compared to a 27% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has fallen by 44% per year, which means it is significantly lagging earnings. Price Target Changed • Jan 05
Price target increased to €5.64 Up from €5.16, the current price target is an average from 4 analysts. New target price is 84% above last closing price of €3.06. Stock is down 0.8% over the past year. The company is forecast to post a net loss per share of US$0.97 next year compared to a net loss per share of US$1.78 last year. Breakeven Date Change • Jan 04
Forecast to breakeven in 2025 The 2 analysts covering DBV Technologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$24.9m in 2025. Average annual earnings growth of 55% is required to achieve expected profit on schedule. Price Target Changed • Dec 16
Price target decreased to €5.16 Down from €5.70, the current price target is an average from 4 analysts. New target price is 101% above last closing price of €2.57. Stock is down 49% over the past year. The company is forecast to post a net loss per share of US$1.11 next year compared to a net loss per share of US$1.78 last year. Reported Earnings • Nov 05
Third quarter 2022 earnings: EPS and revenues exceed analyst expectations Third quarter 2022 results: US$0.18 loss per share (improved from US$0.44 loss in 3Q 2021). Net loss: US$17.3m (loss narrowed 28% from 3Q 2021). Revenue exceeded analyst estimates by 117%. Earnings per share (EPS) also surpassed analyst estimates by 24%. Revenue is forecast to grow 2.3% p.a. on average during the next 3 years, compared to a 24% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 47% per year but the company’s share price has fallen by 40% per year, which means it is significantly lagging earnings. Major Estimate Revision • Sep 23
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$0.91 to -US$1.07 per share. Revenue forecast unchanged at US$6.78m. Biotechs industry in France expected to see average net income growth of 8.6% next year. Consensus price target of €5.70 unchanged from last update. Share price fell 14% to €3.76 over the past week. Major Estimate Revision • Sep 07
Consensus EPS estimates fall by 11% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from US$7.09m to US$6.72m. Losses expected to increase from US$0.82 per share to US$0.92. Biotechs industry in France expected to see average net income growth of 8.6% next year. Consensus price target of €5.75 unchanged from last update. Share price rose 5.2% to €4.34 over the past week. Major Estimate Revision • Aug 08
Consensus revenue estimates increase by 53% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$4.78m to US$7.32m. Forecast losses expected to reduce from -US$1.19 to -US$0.85 per share. Biotechs industry in France expected to see average net income growth of 9.8% next year. Consensus price target up from €4.98 to €5.75. Share price rose 11% to €5.12 over the past week. Reported Earnings • Aug 02
Second quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2022 results: US$0.35 loss per share (up from US$0.56 loss in 2Q 2021). Net loss: US$23.0m (loss narrowed 25% from 2Q 2021). Revenue exceeded analyst estimates by 29%. Earnings per share (EPS) missed analyst estimates by 28%. Over the next year, revenue is expected to shrink by 36% compared to a 103% growth forecast for the industry in France. Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has fallen by 34% per year, which means it is significantly lagging earnings. Major Estimate Revision • May 10
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$1.41 to -US$1.23 per share. Revenue forecast steady at US$4.98m. Biotechs industry in France expected to see average net income growth of 2.1% next year. Consensus price target of €5.53 unchanged from last update. Share price was steady at €2.50 over the past week. Reported Earnings • May 03
First quarter 2022 earnings: EPS and revenues exceed analyst expectations First quarter 2022 results: US$0.30 loss per share (up from US$0.54 loss in 1Q 2021). Net loss: US$16.7m (loss narrowed 43% from 1Q 2021). Revenue exceeded analyst estimates by 106%. Earnings per share (EPS) also surpassed analyst estimates by 29%. Over the next year, revenue is forecast to grow 5.4%, compared to a 165% growth forecast for the industry in France. Over the last 3 years on average, earnings per share has increased by 45% per year but the company’s share price has fallen by 47% per year, which means it is significantly lagging earnings. Board Change • Apr 27
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Scientific Adviser to the CEO & Chairman of Scientific Advisory Board Hugh Sampson was the last director to join the board, commencing their role in 2020. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Mar 05
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: US$1.78 loss per share (up from US$2.95 loss in FY 2020). Net loss: US$97.8m (loss narrowed 39% from FY 2020). Revenue exceeded analyst estimates by 20%. Earnings per share (EPS) missed analyst estimates by 7.5%. Over the next year, revenue is expected to shrink by 10% compared to a 297% growth forecast for the pharmaceuticals industry in France. Over the last 3 years on average, earnings per share has increased by 42% per year but the company’s share price has fallen by 45% per year, which means it is significantly lagging earnings.