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VALNEVA Reports Nine Month Results for 2018, Confirms Guidance, Strengthens Balance Sheet with €50m FinancingValneva Reports Nine Month Results for 2018, Confirms Guidance, Strengthens Balance Sheet with €50m Financing On track to deliver on multiple key business and R&D milestones
On track to deliver against full year revenues and EBITDA guidance
David Lawrence, Valneva's Chief Financial Officer, commented, "The important milestones that we have achieved during the year reflect the continued execution against our business and R&D objectives. The €50 million financing is a notable achievement to strengthen our shareholder base as we plan our capital needs for future R&D investments, notably the upcoming Lyme Phase 3. Our achievements in the year to date also give us confidence to confirm that we will meet both our business and R&D objectives for the year." Key Financial Information
Saint Herblain (France), November 8, 2018 - Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, reported today its consolidated financial results for the first nine months of the year ended September 30, 2018. The condensed consolidated interim financial results are available on the Company's website www.valneva.com. A webcast for the financial community and media will be held today at 2:00 pm (CET). A replay will be available on the Company's website. Please refer to this link: https://edge.media-server.com/m6/p/4awwekgc Commercial Vaccines JAPANESE ENCEPHALITIS VACCINE (IXIARO®/JESPECT®) In the first nine months of 2018, revenues from IXIARO®/JESPECT® product sales reached €50.0 million, compared to €45.7 million in the first nine months of 2017. The increase was largely driven by demand in the US, including in the private market where Valneva has taken direct control of sales and marketing. There was also a strong increase in IXIARO® sales in Canada in the nine-month period in 2018 compared to the same period in 2017. Last month, Valneva announced that the U.S. Food and Drug Administration ("FDA") approved an accelerated IXIARO® vaccination schedule of two doses administered seven days apart. This new schedule is an alternate to the existing 28 day schedule providing travelers and healthcare professionals with commensurate flexibility. Based on nine-month sales and anticipated fourth-quarter supplies, Valneva reaffirms its double-digit growth expectations for IXIARO®/JESPECT® sales in 2018 compared to 2017. Valneva expects to enter into a new supply contract with the US DoD by the end of 2018. CHOLERA / ETEC[3]-DIARRHEA VACCINE (DUKORAL®) In the first nine months of 2018, revenues from DUKORAL® sales reached €18.6 million, compared to €19.9 million in the first nine months of 2017. The strong sales volume performance in Canada in the first nine months of the year was eroded by a combination of adverse exchange rate movements (mainly between the Canadian dollar and the Euro) and supply constraints. Noting that seasonality of demand will drive strong fourth quarter sales, Valneva is confident that it will report increased DUKORAL® sales in the second half of 2018 compared to the first half of 2018 and that full-year 2018 sales will meet 2017 levels. Research and Development Valneva's Clinical Stage R&D programs are progressing well with key value inflection milestones according to market guidance. R&D investments amounted to €18.2 million in the first nine months of the year and the Company now expects that the investment level for R&D in the full year will be in the range of €25 million - €30 million compared to €30 million - €35 million previously. This reflects the phasing of costs relating to external CRO and CMO partners as well as a more efficient and focused use of R&D resources. Clinical Stage Vaccine Candidates LYME DISEASE VACCINE CANDIDATE - VLA15 Valneva is finalizing its Phase 2 preparations and re-confirms its expectation to initiate Phase 2 clinical development at the end of 2018. It is planned that the Phase 2 studies will include approximately 800 subjects across more than 10 study sites in the U.S. and Europe. The studies are planned to include both participants that have previously been exposed to Lyme as well a participants that have not previously experienced Lyme infection. Phase 2 will evaluate further dosages and schedules in addition to those evaluated in Phase 1. The final dose and schedule for Phase 3 will be determined based on the immunogenicity and safety data generated in the Phase 2 studies. The Phase 2 duration is expected to be approximately two years. The Company recently announced that the European Medicines Agency (EMA) provided positive feedback on the Company's general development approach for its Lyme disease vaccine candidate, VLA15. This EMA's comprehensive scientific advice is largely aligned with previous discussions with the US FDA. Lyme disease is the most common vector-borne illness in the northern hemisphere for which there is no other clinical vaccine candidate in development worldwide. According to the US Centers for Disease Control and Prevention (CDC), approximately 300,000[4] Americans are infected with Lyme disease annually with at least a further 200,000 cases in Europe[5]. Valneva's vaccine candidate VLA15, under Fast Track Designation by the FDA, is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia and is intended to protect against the majority of human pathogenic Borrelia species. VLA15 is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite. The global market for a vaccine for Lyme disease is currently estimated at approximately €700 - €800 million annually[6]. CHIKUNGUNYA VACCINE CANDIDATE - VLA1553 Valneva expects to release the primary endpoint data (safety data at day 28) and secondary endpoint date (immunogenicity at day 28, dosage) by the end of the year. As recently announced, the Company has now commenced the second stage of its Phase 1 study. A first group of study participants is now being re-vaccinated with the highest vaccine dose. This re-vaccination is intended to provide an intrinsic human challenge early in the VLA1553 clinical development, with the goal of demonstrating that subjects are protected from vaccine-induced viremia. The Phase 1 study VLA1553-101 is a randomized, observer-blinded, dose-escalation, multi-center study. It is investigating three different dose levels of VLA1553 in approximately 120 healthy adults, initially vaccinated with a single-shot immunization. Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. As of 2017, there have been more than one million reported cases in the Americas[7] and the economic impact is considered significant (e.g. Colombia outbreak 2014: $73.6 million)[8]. The medical burden is expected to grow as the distribution of the CHIKV primary mosquito vectors continues to spread further geographically. There are no preventive vaccines or effective treatments available and as such, Chikungunya can be considered a major public health threat. VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate aiming for protection against various Chikungunya virus outbreak phylogroups and strains designed for long-lasting protection conferred by neutralizing antibodies in adults and children[9]. In pre-clinical development, a single-vaccine shot was highly immunogenic, eliciting a strong, long lasting neutralizing antibody response. Vaccinated non-human primates (NHP) (cynomolgus macaques) showed no signs of viremia after challenge[10]. The target populations for vaccines against Chikungunya are travelers, military personnel or individuals at risk who live in endemic regions. The global market is estimated to be worth up to €500 million annually6. ZIKA VACCINE CANDIDATE - VLA1601 Valneva is currently in the data analysis phase for its Phase 1 Zika vaccine candidate VLA1601, partnered with Emergent BioSolutions and expects to release data (safety and immunogenicity at day 56) in the next few weeks. The Phase 1 study VLA1601-101 is a randomized, observer-blinded, placebo-controlled, single center study investigating two dose levels with two different vaccination schedules in 67 healthy adults. Zika Virus infection is a mosquito-borne viral disease caused by the Zika Virus (ZIKV), a flavivirus transmitted by Aedes mosquitoes[11]. Disease outbreaks have been reported in tropical Africa, South-East Asia, the Pacific Islands, and, since 2015, in the Americas. According to the World Health Organization (WHO), there is scientific consensus that the ZIKV is a cause of microcephaly and Guillain-Barré syndrome[12]. Between 2015 and early January 2018, over 500,000 cases of suspected Zika infection and many cases of the congenital syndrome associated with the ZIKV were reported by countries and territories in the Americas, according to the WHO[13]. There is currently no specific treatment available. VLA1601 is a highly purified inactivated whole virus vaccine candidate developed using Valneva's proven and licensed inactivated JE vaccine platform. In pre-clinical development, VLA1601 demonstrated excellent purity, in-vivo neutralization and overall a biological, chemical and physical profile comparable to IXIARO®. First nine months 2018 Financial Review Revenues Operating result and EBITDA Net result Cash flow and liquidity About Valneva SE
Forward-Looking Statements [1] CER growth: In order to illustrate underlying performance, Valneva has decided to include information on its results in terms of constant exchange rate (CER) growth. This represents growth calculated as if the exchange rates used to determine the results of overseas companies in Euros had remained unchanged from those used in the comparative period. CER% represents growth at constant exchange rates. AER% represents growth at actual exchange rates. [2] For greater clarity, reporting of grants has been re-classified and will,as of 2018, be included in the Company's Other Income / Expense line. The comparator period of 2017 was adjusted accordingly. [3] Indications differ by country -Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. [4] As estimated by the CDC https://wwwnc.cdc.gov/eid/article/21/9/15-0417_article [5] As estimated from available national data. Case reporting is highly inconsistent in Europe and many LB infections still go undiagnosed. [6] Company estimate supported by independent market studies [7] PAHO/WHO data: Number of reported cases of Chikungunya Fever in the Americas - EW 51 (December 22, 2017) [8] Cardona-Ospina et al., Trans R Soc Trip Med Hyg 2015 [9] Hallengärd et al. 2013 J. Virology 88: 2858-2866 [10] Roques et al. 2017JCI Insight 2 (6): e83527 [11] https://www.cdc.gov/zika/transmission/index.html [12] http://www.who.int/mediacentre/factsheets/zika/en/ [13]http://www.paho.org/hq/index.php?option=com_content&view=article&id=12390&Itemid=42090&lang=en Attachment |