Research analysts who have asked questions during Valneva earnings calls.
Vamil Divan
Guggenheim Securities
4 questions for VALN
Also covers: ABBV, ABSI, ANIP +7 more
MR
Maury Raycroft
Jefferies
3 questions for VALN
Also covers: ABEO, ALNY, ARWR +11 more
RS
Rajan Sharma
Goldman Sachs Group, Inc.
3 questions for VALN
Also covers: ARGX, AUTL, AZN +6 more
MR
Maurice Raycroft
Jefferies Financial Group
2 questions for VALN
Also covers: ABEO, AFMD, ALNY +14 more
Oscar Haffen Lamm
Bryan Garnier & Co.
2 questions for VALN
RO
Romy O'Connor
VLK
2 questions for VALN
Samir Devani
Rx Securities
2 questions for VALN
Also covers: BTAI
SS
Simon Scholes
First Berlin
2 questions for VALN
Also covers: PHAR
Suzanne van Voorthuizen
Kempen & Co
2 questions for VALN
Also covers: ARGX, BNTX, GMAB +3 more
TR
Theodora Rowe Beadle
Goldman Sachs
2 questions for VALN
Damien Choplain
Stifel
1 question for VALN
SV
Sebastian Vandishot
Van Lanschot Kempen
1 question for VALN
Recent press releases and 8-K filings for VALN.
Valneva withdraws U.S. Chikungunya vaccine applications
VALN
- Valneva SE has voluntarily withdrawn its Biologics License Application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, IXCHIQ®, in the United States.
- This decision follows the U.S. Food and Drug Administration (FDA)'s suspension of the license in August 2025 and a subsequent clinical hold on the IND due to a newly reported foreign Serious Adverse Event (SAE).
- The SAE, which occurred outside the U.S. and involved a younger adult receiving multiple vaccines, may be plausibly related to IXCHIQ® vaccination, though causality has not been determined.
- There are no active clinical studies involving IXCHIQ® currently vaccinating participants, but the company plans to proceed with post-marketing clinical activities and the vaccine remains licensed in Europe, Canada, the United Kingdom, and Brazil.
Jan 20, 2026, 2:50 PM
Valneva Reports Positive Final Phase 2 Results for Chikungunya Vaccine IXCHIQ in Children
VALN
New Projects/Investments
- Valneva announced positive final Phase 2 antibody persistence and safety results for its single-shot chikungunya vaccine, IXCHIQ®, in 304 children aged one to eleven years.
- The vaccine was well tolerated, and antibody levels remained high after twelve months, with the full dose demonstrating a 94.7% seroresponse rate in CHIKV-naïve children at Day 360.
- These results support the selection of the full dose for a future Phase 3 trial in children.
- The company plans to initiate the Phase 3 study in children after gathering additional real-world experience in the adolescent population, a decision made in alignment with regulatory authorities.
Dec 11, 2025, 11:26 AM
Valneva announces positive final Phase 2 data for IXCHIQ® chikungunya vaccine in children
VALN
New Projects/Investments
- Valneva SE announced positive final antibody persistence and safety data from its Phase 2 clinical trial for its single-shot chikungunya vaccine, IXCHIQ®, in 304 children aged one to eleven years, twelve months post-vaccination.
- The study showed that the full dose of IXCHIQ® elicited a higher immune response, with a 94.7% seroresponse rate in CHIKV-naïve children at Day 360, and the vaccine was well tolerated with no safety concerns identified.
- These results support the selection of the full dose for future Phase 3 development in children, which the company plans to initiate after gathering additional real-world experience in the adolescent population.
Dec 10, 2025, 4:45 PM
Valneva SE Reports Nine-Month 2025 Financial Results and Confirms Full-Year Guidance
VALN
Earnings
Guidance Update
New Projects/Investments
- Valneva SE reported total revenues of €127.0 million and product sales of €119.4 million for the first nine months of 2025, an increase from €116.6 million and €112.5 million respectively in the same period of 2024.
- The company posted a net loss of €65.2 million for the first nine months of 2025, contrasting with a net profit of €24.7 million in the prior year, which benefited from a €90.8 million gain from a Priority Review Voucher (PRV) sale.
- Cash and cash equivalents were €143.5 million at the end of September 2025, supported by a significant reduction in operating cash burn to €28.4 million and a successful debt refinancing in October 2025.
- Valneva confirmed its full-year 2025 financial outlook, projecting product sales between €155-170 million and total revenues between €165-180 million. The Lyme disease Phase 3 study VALOR remains on track, with results anticipated in the first half of 2026.
Nov 26, 2025, 1:20 PM
Valneva Reports Positive Phase 2 Lyme Vaccine Data and 9M 2025 Financials
VALN
New Projects/Investments
Earnings
Debt Issuance
- Valneva announced positive final Phase 2 immunogenicity and safety data for its Lyme disease vaccine candidate, VLA15, demonstrating a strong immune response and favorable safety profile six months after a third booster dose.
- The three-dose primary vaccination schedule for VLA15 achieved a geometric mean fold rise in antibody levels ranging from 9.5-fold to 15.6-fold, with the highest responses observed in children aged 5 to 11 years.
- Valneva's partner, Pfizer, intends to submit regulatory filings for VLA15 in 2026, pending successful Phase 3 data.
- Financially, Valneva reported a net loss of €65.2 million in the first nine months of 2025, though it improved financial flexibility through debt refinancing and reduced operating cash burn.
Nov 26, 2025, 6:48 AM
Valneva Reports Q3 2025 Financial Results and Provides Business Update
VALN
Earnings
Guidance Update
Product Launch
- Valneva reported total revenues of EUR 127 million for the first nine months of 2025, an increase of 9% over the prior year, with product sales reaching EUR 119.4 million.
- The company significantly reduced its operating cash burn and reported a cash position of EUR 143.5 million as of September 30, 2025, after successfully completing its debt refinancing.
- Valneva confirmed its full fiscal year 2025 financial guidance, projecting product sales between EUR 155 million and EUR 170 million and total revenues between EUR 165 million and EUR 180 million.
- The Phase 3 readout for the Lyme disease vaccine (VLA15) is expected in the first half of 2026, with regulatory submissions planned for 2026 and a potential launch in autumn 2027.
- The U.S. license for the chikungunya vaccine (IxchIQ) remains suspended, impacting sales, while the company secured additional marketing authorizations in the U.K. and Brazil.
Nov 20, 2025, 2:00 PM
Valneva Reports Q3 2025 Financial Results and Provides Pipeline Updates
VALN
Earnings
Guidance Update
New Projects/Investments
- Valneva reported total revenues of EUR 127 million for the first nine months of 2025, an increase of almost 9% year-over-year, primarily driven by product sales of EUR 119.4 million. The company recorded an operating loss of EUR 53.9 million for the period, compared to an operating profit of EUR 34.2 million in the prior year, which included the sale of a priority review voucher.
- IXIARO sales increased by 12.5% to EUR 74.3 million, while DUKORAL sales decreased slightly to EUR 21.5 million. IXCHIQ sales reached EUR 7.6 million, up from EUR 1.8 million in the first nine months of 2024, but were significantly impacted by the U.S. license suspension.
- For its Lyme disease vaccine (VLA15), the Phase III readout is anticipated in the first half of 2026, with regulatory submissions planned for 2026 and a launch expected in autumn 2027. The IXCHIQ vaccine's U.S. license remains suspended, though additional marketing authorizations were secured in the U.K. and Brazil.
- The company's cash position stood at EUR 143.5 million as of September 30, 2025, following a successful debt refinancing. Valneva reaffirmed its full-year 2025 guidance with product sales projected between EUR 155 million and EUR 170 million, and total revenues between EUR 165 million and EUR 180 million.
Nov 20, 2025, 2:00 PM
Valneva Reports Q3 2025 Financial Results and Provides Business Updates
VALN
Earnings
Guidance Update
New Projects/Investments
- Valneva reported total revenues of EUR 127 million and product sales of EUR 119.4 million for the first nine months of 2025, representing a 9% and 6.2% increase respectively.
- The company successfully completed its debt refinancing and significantly reduced its operating cash burn, ending Q3 2025 with a cash position of EUR 143.5 million.
- Valneva confirmed its financial guidance for fiscal year 2025, projecting product sales of EUR 155-170 million and total revenues of EUR 165-180 million.
- For its Lyme disease vaccine (VLA15), Pfizer reconfirmed regulatory applications in the U.S. and Europe in 2026, with a readout expected in H1 2026 and a launch in autumn 2027.
- The Chikungunya vaccine (IxchIQ) secured additional marketing authorizations in the U.K. and Brazil, but its U.S. license suspension significantly impacted sales, with the company awaiting further information from the FDA.
Nov 20, 2025, 2:00 PM
Valneva Reports Nine-Month 2025 Financial Results and Confirms Full-Year Guidance
VALN
Earnings
Guidance Update
New Projects/Investments
- Valneva SE reported total revenues of €127.0 million and product sales of €119.4 million for the first nine months of 2025, an increase of 8.9% and 6.2% respectively, compared to the same period in 2024.
- The company recorded a net loss of €65.2 million for the first nine months of 2025, primarily due to the absence of the €90.8 million net gain from the sale of a Priority Review Voucher that boosted 2024 results.
- Cash and cash equivalents stood at €143.5 million as of September 30, 2025, with a significant reduction in operating cash burn to €28.4 million for the first nine months of 2025, down from €76.7 million in the prior year.
- Valneva reiterated its full-year 2025 financial guidance, expecting total revenues between €165-180 million and product sales between €155-170 million.
- The Phase 3 VALOR study for its Lyme disease vaccine candidate (VLA15) is on track, with trial outcomes expected in the first half of 2026.
Nov 20, 2025, 11:04 AM
Valneva Provides Updates on Lyme Vaccine Timeline, IXCHIQ BLA, and Financial Outlook
VALN
Guidance Update
New Projects/Investments
Product Launch
- Valneva's Lyme vaccine (VLA15) Phase 3 data readout is now expected in the first half of 2026, revised from year-end 2025, to allow for a three-month safety update.
- Regulatory submissions for VLA15 are anticipated in mid-2026, with approval expected early-mid 2027, and commercialization by late 2027 ahead of the 2028 tick season.
- The Lyme vaccine is projected to be a >$1 billion global market opportunity annually, with Valneva receiving tiered royalties between 14% and 22% and sales milestones of up to $100 million, which is expected to drive sustained profitability by 2027.
- The FDA suspended the Biologics License Application (BLA) for Valneva's chikungunya vaccine, IXCHIQ, in August 2025 due to new SAEs, and the company is awaiting FDA feedback after responding in early October 2025.
- Valneva maintains an annual product sales guidance of EUR 155 million-EUR 170 million.
Nov 19, 2025, 2:00 PM
Quarterly earnings call transcripts for Valneva.
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