Valneva Maintains 2026 Revenue Guidance After First-Half Sales Decline

Valneva (NASDAQ: VALN ) released second-quarter financial results and hosted an earnings call on Thursday. Read the complete transcript below. This content is powered APIs. For comprehensive financial data and transcripts, visit View the webcast at Summary Valneva reported a strong cash position of over €120 million, supported by disciplined cash management and proceeds from a recent offering.

The company has undergone restructuring, including workforce reduction and project reprioritization, expecting positive financial impacts in the second half of 2026. Product sales for the first half of 2026 totaled €64 million, a decrease from €91 million in the first half of 2025, with specific decreases in IXIARO and Dukoral sales due to distributor transitions and sales phasing. The Lyme disease vaccine candidate, developed in partnership with Pfizer, has shown promising efficacy and safety results, with regulatory decisions expected in the next 12 months.

Valneva is focusing on expanding its presence in low- and middle-income countries, particularly with the IXCHIQ vaccine, and is executing post-marketing activities supported by CEPI. R&D expenses decreased as a result of reprioritization, while SG&A expenses also saw reductions due to lower personnel and other cost efficiencies. The company maintains its financial guidance for 2026, with expected product sales between €135 and €150 million, and total revenues between €145 and €160 million. Future strategic focus includes leveraging vaccine development expertise to build a risk-balanced portfolio and maximizing cash generation from commercial operations.

Full Transcript Josh, Investor Relations Hello and thank you for joining us to discuss Valneva's financial results for the first half 2026 and corporate update. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the six months ended June 30, 2026, which were published earlier today, available within the Financial Report section on our investor website. I'm joined today by Valneva CEO Thomas Lingelbach and our CFO Peter Buhler, who will provide an overview and update on our business as well as our financial results.

There will be an analyst Q&A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners that during this presentation we will be making forward-looking statements which are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You can find information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website.

Please note that today's presentation includes information provided as of today, August 13, 2026, and Valneva undertakes no obligation to revise or update forward-looking statements except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation. Thomas Lingelbach, CEO Thank you so much, Josh. Good day everyone.

Let me start off with a couple of introductory remarks. The first half of 2026 has certainly been marked on our effort to focus on enhancing our financial position, especially after the initial Lyme Phase 3 VALOR results and the resulting uncertainty, and we have been able to generate a strong cash position with more than €120 million in cash. This is a result of our disciplined cash management and the proceeds from the recent offering. We also included a broad restructuring program and we expect the positive P&L and cash flow impacts in the second half of this year and of course beyond.

This included a reduction in our workforce, a reprioritization of projects and activities, and a focus on our core operational business. When we look at our general commercial business performance, we generated more than 60 million in total product sales. We have reaffirmed the guidance because the half-year sales performance is in line with our anticipated phasing of product sales throughout the year 2026. We have had a number of adverse EBIT impacts in the first half of the year.

Peter will explain those in greater detail. Most of them are really one-off effects and are non-recurring. But the most important thing and the most exciting thing is that Pfizer continued to be very positive about the prospect of the Lyme disease vaccine. And they recently announced during their earnings that they expect regulatory decisions for the Lyme disease vaccine candidate in the next 12 months, which is really great news.

Now turning to our general business update and of course I would like to start with Lyme. You know that the vaccine showed a very strong point efficacy greater than 70%, a very good safety profile and, as we discussed multiple times, we had a miss on the lower bound of the 95% confidence interval. However, we have to note that we see here with this product candidate a very significant leaning for meaningful efficacy and we had also a 95% confidence interval lower bound greater than 20% in the second pre-specified analysis.

All of that, in combination with the huge unmet medical need, the totality of clinical evidence and the fact that we really expect a positive health economical benefit for a potential prophylactic solution, increases our confidence in the future prospect of a potential Lyme vaccine. There is a huge unmet medical need. We have discussed this many times in the past. The annual burden of disease is increasing and we have been noting recently close to 500,000 cases in the United States.

Europe, I mean numbers are kind of still significantly underreported because not all countries have respective surveillance systems, but certainly north of 100,000 cases every year. Some of them come along with very severe manifestations in the order of 10 to 30%: carditis, neuroborreliosis, arthritis, and unfortunately 5 to 10% of cases continue to have persistent symptoms even following treatment. As such, we really believe that LB6V, how it's called now, is a compelling opportunity in a highly underserved market. We could really leverage a first-mover advantage.

The perception around a need for Lyme vaccination is high. We have the only Lyme disease vaccine candidate in late-stage clinical development and it could become, if licensed, the first potential Lyme vaccine in nearly 30 years. The vaccine is based on a proven mode of action. We cover the six key serotypes prevalent in the Northern Hemisphere and the technology is based on modern state-of-the-art recombinant protein technology.

We have a broad addressable population at this point in time. We showed in the study results for people above 5 years of age. I mentioned already that we see a growing disease burden and of course with global warming, the tick population across all the high-risk areas of Lyme disease are steadily increasing. As part of our overall restructuring process and also reprioritization of our key strategic focus areas, we shift more and more towards the IXCHIQ access in countries where there is highest risk for Chikungunya infection, meaning primarily low- and middle-income countries.

And we are currently executing on a significant number of post-marketing activities all supported by our great partner CEPI. We have a pilot vaccination campaign ongoing in Brazil. We have more than 50,000 people already vaccinated today. These are adults 18 to 59 years of age.

We have a study ongoing to confirm effectiveness and optimize description of the safety profile, which of course over time could potentially even lift the highly restrictive warnings, precautions and other indications we have right now in our label for travel. All of that of course to ensure greater access. And we are focusing a lot right now on expanding our network of manufacturing and distribution partners in low- and middle-income countries. And we hope that we will be able to even announce something towards the latter part of the year.

The locally manufactured vaccine in Brazil by our partner Butantan has now been approved and is expected to be incorporated into Brazil's public health system in the near future. We license an interesting candidate against Shigellosis. It's the most clinically advanced tetravalent Shigella vaccine candidate. Right now we are running two studies, one in infants, the other one in adults.

One is an immunogenicity and safety study. The other one is a controlled human infection model study, so pilot efficacy through human challenge. We expect for both studies results in the coming months and of course based on the results we will decide on the next development steps for that vaccine. Of course there is still a significant market opportunity for Shigellosis, especially given that it's the second leading cause of fatal diarrheal disease and estimated with 165 million cases and 600 deaths annually, mostly of course in children in LMIC countries.

But there is also a very interesting opportunity either in a stand-alone setting or in a combination vaccine setting to work towards a product covering diarrheal vaccine for travelers. With this short update on our core R&D activities and general business development, I would like to hand over to Peter to provide you with the financial report. Peter Buhler, Chief Financial Officer Yeah, thank you, Thomas. So first, looking at product sales: product sales reached €64 million compared to €91 million in the first half of 2025.

3% versus prior year at constant currency. This decrease was primarily due to product-specific effects which I will discuss shortly. 7 million in the prior year's first half. S.

Department of Defense. S. Department of Defense in the first half of 2026 continued under the one-year contract signed in January 2025. We expect to sign a new contract in the coming months and begin recording sales under this new contract in the second half of the current fiscal year.

5 million on IXIARO sales during the first half of 2026. 4 million in the first half of 2025. Prior year sales benefited from one-time sales associated with the supply of Dukoral doses to Mayotte in response to a cholera outbreak. In addition, sales in the first half of 2026 were adversely affected by the distributor transition in Germany in January 2026.

Similar to the first quarter, existing inventory transferred from the previous distributor was sufficient to meet market demand during the period. Furthermore, there was a slight weakening of the travel market in certain geographies due to geopolitical factors. 5 million in the first half of 2025. While current year sales include the first shipment of drug substance to our Brazilian partner, Instituto Butantan, the prior year benefited from 40,000 doses sold to the French island La Réunion in response to a major chikungunya outbreak as well as travel sales in the United States.

In light of the slow product uptake in travel, the company is currently evaluating its future commercial strategy for IXCHIQ, including a potential focus on the endemic markets. 0 million in the first six months of 2026. This planned reduction is the result of key third-party distribution agreements that ended in December 2025 without renewal. 6 million in the first half of 2025.

The decrease is mostly related to the lower product sales. Last year's other revenues also included a one-off upfront payment related to the licensing agreement with the Serum Institute of India for a single-shot chikungunya vaccine. 2 million during the same period last year. 5 million non-cash impairment of excess IXCHIQ inventory resulting from lower than anticipated sales.

In addition, cost of goods were adversely impacted by changes in manufacturing schedule and volumes and related adverse variances, as well as higher idle costs. 5% in the prior year. The decrease is mainly related to lower volumes and an unfavorable change in the manufacturing schedule. Last year's IXIARO gross margin was exceptionally high due to high manufacturing volumes and related favorable overhead absorption.

9% in the first half of 2025. The gross margin of Dukoral in the first half of 2026 was adversely impacted by higher-than-usual failed batch costs and inventory revaluation. In contrast, the prior year gross margin benefited from favorable overhead absorption due to manufacturing timing and higher volumes. The IXCHIQ gross margin was negative due to the one-time cancellation fees provisioned in the second quarter as well as the inventory write-down mentioned previously, which importantly had no cash impact.

2 million in the first half of 2026. That decrease is mainly a result of reprioritization and rescheduling of R&D activities. 5 million in the first half of 2026. The decrease is related to a planned reduction in advertising and promotion related to IXCHIQ, as well as reduced personnel, warehousing, and distribution costs.

0 million in the first half of 2025. The reduction was a result of lower personnel cost and savings in advisory and professional fee services. 2 million related to that program. Savings are expected in the second half year and beyond.

8 million in the prior year. 0 million in the prior year. 6 million at the end of fiscal year 2025. 9 million in the first half of the prior year.

Now, moving to the next slide, to slide 18, we confirm our financial guidance for the fiscal year 2026 with product sales of €135 to €150 million and total revenues of €145 to €160 million. S. Department of Defense for the supply of IXIARO in the coming months. We expect our commercial business to continue generating positive cash flow, and the restructuring program implemented in June will have a positive impact on the P&L and cash flow in the second half of the current fiscal year and beyond.

We expect product-related gross margin to improve in the second half following the non-recurrent effects in the first half of the year. We continue to see potential to become financially self-sustainable starting in 2026, pending successful regulatory approval of the Lyme disease vaccine and subsequent commercialization by Pfizer. With this, I hand the call back to Thomas. Thomas Lingelbach, CEO Thank you so much, Peter.

Peter said 2026; we mean 2027, of course. Also, it would be nice to be already in 2026 financially sustainable. Yeah, let me close by giving a little bit of prospect on how we see the future of Valneva. Of course, provided and subject to Lyme success going forward, we would really like to leverage the company's core strength in vaccine development to deliver greater long-term value.

We would like to build scale in the R&D pipeline once Lyme has been out of pipeline and hopefully successfully brought to market. We see here a clear opportunity for strategic in-licensing to augment our clinical-stage pipeline, and what we would like to do is really to create a risk-balanced portfolio of innovative specialty, lifecycle, and high-value vaccine assets which are attractive and go very much beyond our prior focus on vector-borne diseases. We are working with a team to target new assets based on defined criteria and new targeted disease areas.

In parallel, we are advancing our internal earlier-stage candidates, such as EBV or ETEC—a broader enteric disease-covering candidate program—and we would like to put also emphasis on focusing on reducing antimicrobial resistance targets. All of that will be flanked by further optimizing our integrated operations. We have kicked off a number of initiatives already as part of our restructuring program this year, and this mainly focuses on adapting and adjusting our value chains, changes of custody, make versus buy, external manufacturing partners, but also a continuous focus on optimizing our commercial models.