Latest news with #IXCHIQ
Yahoo
2 days ago
- Business
- Yahoo
Valneva SE (INRLF) (H1 2025) Earnings Call Highlights: Robust Revenue Growth Amid Operational ...
Total Revenue: EUR97.6 million, a 37.8% increase from EUR70.8 million in the first half of 2024. Product Sales: EUR91 million, up 33.3% from EUR68.3 million in the first half of 2024. IXIARO Sales: EUR54.7 million, a 30.6% increase year-over-year. DUKORAL Sales: EUR17.4 million, a 16.4% increase year-over-year. IXCHIQ Sales: EUR7.5 million, up from EUR1 million in the first half of 2024. Gross Margin (excluding IXCHIQ): 59.2%, up from 47.7% in the prior year. IXIARO Gross Margin: 65.5%, compared to 57.5% in the first half of 2024. DUKORAL Gross Margin: 52.9%, compared to 34.8% last year. Operating Loss: EUR16.8 million, compared to an operating profit of EUR46.7 million last year. Adjusted EBITDA: Minus EUR6 million, compared to a positive EUR56.2 million last year. Cash Position: EUR161.3 million as of June 30, 2025. Cash Used in Operations: EUR10.9 million, down from EUR66.3 million in the first half of 2024. 2025 Financial Guidance: Product sales of EUR170 million to EUR180 million; total revenues of EUR180 million to EUR190 million. Warning! GuruFocus has detected 8 Warning Signs with INRLF. Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Valneva SE (INRLF) achieved significant year-over-year revenue growth, reaching close to EUR100 million in the first half of 2025. The company maintained a strong cash position of over EUR160 million, indicating effective cash management and reduced operating cash burn. Valneva SE (INRLF) secured additional marketing authorizations for its chikungunya vaccine, IXCHIQ, in the UK, Brazil, and Europe, expanding its market reach. The Lyme disease vaccine candidate, VALOR, is progressing as planned, with Pfizer aiming for regulatory submissions in 2026. The company reported positive Phase III pediatric safety and immunogenicity results for IXCHIQ, reinforcing its potential in the market. Negative Points Valneva SE (INRLF) reported an operating loss of EUR16.8 million in the first half of 2025, compared to an operating profit in the previous year. The company experienced adverse foreign currency fluctuations, impacting revenues by EUR500,000. Research and development expenses increased, driven by costs related to the Shigella vaccine candidate. The company faced temporary restrictions on its chikungunya vaccine, IXCHIQ, due to safety concerns, impacting market uptake. Valneva SE (INRLF) anticipates an acceleration of R&D costs in the second half of 2025, which could further impact financial performance. Q & A Highlights Q: Regarding the 40,000 doses sold to the French government, should we expect any additional revenue recognition in Q3? Also, could you share your perspective on demand scenarios for IXCHIQ through year-end, considering the evolving CHIKV outbreak in the Indian Ocean and China? A: The 40,000 doses were all shipped in the first half of the year, and the revenue was fully recognized in that period. Regarding demand scenarios, we are in contact with governments where outbreaks are occurring. We have no supply constraints and sufficient material available, but it's too early to state where and how we will respond. We aim to stay in control over potential vaccination campaigns given past experiences. Q: For the Lyme vaccine, could you provide insight on how the reporting of data readouts will transpire at year-end? Will the disclosure only report top-line data, or can we expect detailed results? A: The reporting of Phase III results is under Pfizer's responsibility. We expect data readout in two steps: a report on top-line data, primarily efficacy numbers, followed by communication on other endpoints. All data should be out by the end of the first quarter, supporting regulatory submissions around mid-next year. Q: Could you elaborate on what might trigger an acceleration in IXCHIQ sales uptake within the traveler market? Are you still in discussions with the U.S. for potential stockpiling? A: The uncertainty from safety investigations has impacted market uptake. However, the vaccine's profile, especially as a live-attenuated single-shot vaccine, has advantages for outbreak preparedness. We expect new momentum now that restrictions are lifted and investigations concluded. Discussions on stockpiling will hopefully resume later this year. Q: On the Lyme and VALOR trial, suggests a primary completion date of December 26. Are you confident that Phase III headline data will come in 2025, or could it spill into 2026? What is the bar for success in this trial? A: The primary completion date includes safety follow-up periods. Case counts will continue until the end of October, followed by Pfizer's case adjudication and database cleaning. The timing of data readout is not in our control, but Pfizer reaffirms submission timelines. There is no specific communicated bar for approval, but we expect non-inferiority or superiority compared to past vaccines. Q: What should we expect in terms of financial impact from the distribution agreement with CSL? A: The commercial terms with CSL are similar to our previous agreement, so we do not expect an immediate difference in prospects around Germany. However, as CSL gears up, there may be potential upside in the mid- to long term. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
4 days ago
- Business
- Yahoo
Valneva SE (INRLF) (H1 2025) Earnings Call Highlights: Robust Revenue Growth Amid Operational ...
Total Revenue: EUR97.6 million, a 37.8% increase from EUR70.8 million in the first half of 2024. Product Sales: EUR91 million, up 33.3% from EUR68.3 million in the first half of 2024. IXIARO Sales: EUR54.7 million, a 30.6% increase year-over-year. DUKORAL Sales: EUR17.4 million, a 16.4% increase year-over-year. IXCHIQ Sales: EUR7.5 million, up from EUR1 million in the first half of 2024. Gross Margin (excluding IXCHIQ): 59.2%, up from 47.7% in the prior year. IXIARO Gross Margin: 65.5%, compared to 57.5% in the first half of 2024. DUKORAL Gross Margin: 52.9%, compared to 34.8% last year. Operating Loss: EUR16.8 million, compared to an operating profit of EUR46.7 million last year. Adjusted EBITDA: Minus EUR6 million, compared to a positive EUR56.2 million last year. Cash Position: EUR161.3 million as of June 30, 2025. Cash Used in Operations: EUR10.9 million, down from EUR66.3 million in the first half of 2024. 2025 Financial Guidance: Product sales of EUR170 million to EUR180 million; total revenues of EUR180 million to EUR190 million. Warning! GuruFocus has detected 8 Warning Signs with INRLF. Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Valneva SE (INRLF) achieved significant year-over-year revenue growth, reaching close to EUR100 million in the first half of 2025. The company maintained a strong cash position of over EUR160 million, indicating effective cash management and reduced operating cash burn. Valneva SE (INRLF) secured additional marketing authorizations for its chikungunya vaccine, IXCHIQ, in the UK, Brazil, and Europe, expanding its market reach. The Lyme disease vaccine candidate, VALOR, is progressing as planned, with Pfizer aiming for regulatory submissions in 2026. The company reported positive Phase III pediatric safety and immunogenicity results for IXCHIQ, reinforcing its potential in the market. Negative Points Valneva SE (INRLF) reported an operating loss of EUR16.8 million in the first half of 2025, compared to an operating profit in the previous year. The company experienced adverse foreign currency fluctuations, impacting revenues by EUR500,000. Research and development expenses increased, driven by costs related to the Shigella vaccine candidate. The company faced temporary restrictions on its chikungunya vaccine, IXCHIQ, due to safety concerns, impacting market uptake. Valneva SE (INRLF) anticipates an acceleration of R&D costs in the second half of 2025, which could further impact financial performance. Q & A Highlights Q: Regarding the 40,000 doses sold to the French government, should we expect any additional revenue recognition in Q3? Also, could you share your perspective on demand scenarios for IXCHIQ through year-end, considering the evolving CHIKV outbreak in the Indian Ocean and China? A: The 40,000 doses were all shipped in the first half of the year, and the revenue was fully recognized in that period. Regarding demand scenarios, we are in contact with governments where outbreaks are occurring. We have no supply constraints and sufficient material available, but it's too early to state where and how we will respond. We aim to stay in control over potential vaccination campaigns given past experiences. Q: For the Lyme vaccine, could you provide insight on how the reporting of data readouts will transpire at year-end? Will the disclosure only report top-line data, or can we expect detailed results? A: The reporting of Phase III results is under Pfizer's responsibility. We expect data readout in two steps: a report on top-line data, primarily efficacy numbers, followed by communication on other endpoints. All data should be out by the end of the first quarter, supporting regulatory submissions around mid-next year. Q: Could you elaborate on what might trigger an acceleration in IXCHIQ sales uptake within the traveler market? Are you still in discussions with the U.S. for potential stockpiling? A: The uncertainty from safety investigations has impacted market uptake. However, the vaccine's profile, especially as a live-attenuated single-shot vaccine, has advantages for outbreak preparedness. We expect new momentum now that restrictions are lifted and investigations concluded. Discussions on stockpiling will hopefully resume later this year. Q: On the Lyme and VALOR trial, suggests a primary completion date of December 26. Are you confident that Phase III headline data will come in 2025, or could it spill into 2026? What is the bar for success in this trial? A: The primary completion date includes safety follow-up periods. Case counts will continue until the end of October, followed by Pfizer's case adjudication and database cleaning. The timing of data readout is not in our control, but Pfizer reaffirms submission timelines. There is no specific communicated bar for approval, but we expect non-inferiority or superiority compared to past vaccines. Q: What should we expect in terms of financial impact from the distribution agreement with CSL? A: The commercial terms with CSL are similar to our previous agreement, so we do not expect an immediate difference in prospects around Germany. However, as CSL gears up, there may be potential upside in the mid- to long term. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
NDTV
06-08-2025
- Health
- NDTV
China Reports More Than 7000 Chikungunya Cases: Symptoms, Risk Factors, Complications And More
More than 7000 cases of chikungunya have been reported in China. Guangdong province in China is the worst-hit area, reporting the maximum number of cases. The US Centres for Disease Control and Prevention (CDC) has issued a Level 2 (Practice Enhanced Precautions) travel alert for all Americans travelling to China. The CDC has also recommended vaccination for travellers visiting an area with a chikungunya outbreak. For the unversed, chikungunya is a viral vector-borne disease. It is transmitted to humans through the bite of infected mosquitoes, primarily the Aedes aegypti and Aedes albopictus species. The virus doesn't spread from person to person through close contact, however, blood transmission may be possible. What are the symptoms of chikungunya? Chikungunya is characterised by a sudden onset of fever and severe joint pain. The incubation period is typically 3-7 days. High fever Severe joint pain and swelling Muscle pain Headache Fatigue Rash Severe joint pain is one of the distinct symptoms of chikungunya, which may last for weeks, months and even years. Older adults or those with pre-existing conditions are also likely to experience severe joint pain, especially during extreme weather conditions. Other symptoms are generally self-limiting and improve within a week. What are the treatment options for chikungunya? Chikungunya treatment mainly focuses on relieving symptoms. Anti-inflammatory medicines and pain killers are usually used to manage fever and joint and muscle pain. Rest and adequate hydration also assist in quick recovery. Is chikungunya fatal? Chikungunya is rarely fatal. However, the elderly, newborns or individuals with pre-existing health conditions remain at a higher risk of severe complications. Most symptoms are generally self-limiting and last for 2-3 days. The disease is characterised by an abrupt onset of fever, which is frequently accompanied by joint pain. Other common signs and symptoms include muscle pain, headache, nausea, fatigue and rash. How to prevent chikungunya Chikungunya prevention involves reducing mosquito exposure and controlling mosquito populations. Effective strategies include: Use insect repellent containing DEET or eucalyptus oil, especially when outdoors Wear long-sleeved clothes and full-length pants to minimise skin exposure Use mosquito nets while sleeping, especially in areas where chikungunya is prevalent Eliminate standing water, as this is where mosquitoes breed Install screens on windows and doors to keep mosquitoes out Stay indoors during peak hours when mosquitoes that transmit chikungunya are most active, especially at dawn and dusk. According to the World Health Organisation, the chikungunya virus was first identified in the United Republic of Tanzania in 1952 and subsequently in other countries in Africa and Asia. Urban outbreaks were first recorded in Thailand in 1967 and in India in the 1970s. Currently, there are two chikungunya vaccines available in the United States: IXCHIQ (a live-attenuated vaccine and VIMKUNYA (a virus-like particle vaccine).
Daily Mirror
06-08-2025
- Health
- Daily Mirror
Chikungunya: Everything we know about deadly virus spreading through China
The chikungunya virus, which is spread by mosquitoes, is rarely fatal but has seen a surge in cases in China after an imported case was detected in Foshan city earlier this month A mosquito-borne virus outbreak has infected more than 7,000 people across at least 13 cities in China, prompting authorities to introduce strict precautions reminiscent of the COVID pandemic - even though the virus cannot be transmitted from person to person. The chikungunya virus, which is only spread through the bite of an infected mosquito and is rarely fatal, has swept rapidly through more than a dozen cities in southern Guangdong province, just north of Hong Kong. Nearly 3,000 cases were reported in the past week alone, according to the BBC. Chikungunya is typically uncommon in China, but infections soared after an imported case was detected in Foshan city on July 8, which has since become the worst-affected area, according to the New York Times. The news comes since reports that the disease could arrive in the UK. In response, authorities in Guangdong have implemented measures similar to those deployed during the COVID pandemic. All infected patients are required to remain in hospital isolation under a mosquito net until they test negative for the virus, according to a translation of Chinese news outlet NF News. Officials are also carrying out door-to-door inspections to ensure stagnant water - where mosquitoes breed - is eliminated. Those who fail to comply can be fined or face criminal charges for "obstructing the prevention of infectious diseases," according to a government flyer translated by the Times, reports the Express. Other measures include the introduction of giant "elephant mosquitoes", whose larvae consume virus-carrying mosquitoes, releasing mosquito-eating fish into local ponds, spraying pesticides and using drones to identify mosquito breeding sites, according to The Times. What is chikungunya? Chikungunya is a mosquito-borne virus that typically causes symptoms such as headache, muscle pain, nausea, fatigue, rash and swollen joints. While most symptoms resolve within two weeks, the "debilitating" joint pain can persist for months or even years, says the World Health Organisation. This joint pain is considered the hallmark symptom of chikungunya. Without it, infected individuals may be misdiagnosed with dengue or Zika, making it challenging to determine how many people actually have chikungunya. First identified in southern Tanzania in the 1950s, its name derives from a Kimakonde word meaning "that which bends up," describing the contorted posture caused by severe joint pain. How does it spread? Chikungunya can only be transmitted via a mosquito bite. However, individuals with the virus can pass it back to non-infected mosquitoes if bitten, allowing those insects to then infect others. The virus is not contagious between humans. Is there a vaccine? There are two vaccines approved for use in the United States: IXCHIQ (for those 18 and older) and VIMKUNYA (for those 12 and older). The CDC recommends vaccination only for travellers heading to areas with active chikungunya outbreaks. Where is chikungunya most common? The Centers for Disease Control and Prevention have issued a warning to U.S. travellers visiting Brazil, Colombia, India, Mexico, Nigeria, Pakistan, Thailand and the Philippines, stating they are at an increased risk. A Level 2 travel alert has also been issued for Foshan city, with the CDC recommending that travellers get vaccinated before their visit. Preventive measures include using insect repellent and wearing long-sleeved shirts and trousers. Pregnant women are advised against travelling to affected regions. What's next? Authorities are bracing for more infections after Hong Kong reported its first case - a 12 year old lad - on Monday.
Yahoo
11-07-2025
- Health
- Yahoo
Valneva Announces Lifting of European Medicines Agency's Temporary Restriction on Use of Chikungunya Vaccine IXCHIQ® in Elderly
Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva's single-dose chikungunya vaccine IXCHIQ® by EMA's safety committee (PRAC). The committee initiated its review at the beginning of May following the occurrence of serious side effects mainly in elderly people with several underlying medical conditions. In a press release published today on its website1, EMA underlined that the vaccine is already contraindicated for people with a weakened immune system and concluded that, for people of all ages, IXCHIQ® should be given when there is a significant risk of chikungunya infection and after a careful consideration of the benefits and risks. Additionally, EMA noted that while most serious side effects occurred in older people, IXCHIQ® is effective at triggering the production of antibodies against the chikungunya virus which may be of particular benefit for older people who are at increased risk of severe chikungunya disease. IXCHIQ® was authorised in the European Union in June 20242 and, in March 2025, the European Commission granted a label extension in adolescents 12 years of age and older3. About ChikungunyaChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years4. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas5. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas6 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.7 About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at Media and Investor Relations Contacts Laetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 Joshua Drumm, Global Investor RelationsM +001 917 815 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as 'could,' 'should,' 'may,' 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'aims,' 'targets,' or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results or new adverse events, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted | European Medicines Agency (EMA)2 Valneva Receives Marketing Authorization in Europe for the World's First Chikungunya Vaccine, IXCHIQ® - Valneva3 2025_02_28_IXCHIQ_Ado_Extension_CHMP_Positive_Opinion_PR_EN_Final.pdf4 5 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). Last accessed 01 Aug 2023.7 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment 2025_07_11_EMA_IXCHIQ_Restrictions_Lifting_PR_EN_FinalError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
