Emergent Biosolutions Inc Stock Price, News & Analysis

Emergent BioSolutions Inc. (NYSE:EBS) has received FDA acceptance for its supplemental New Drug Application (sNDA) for NARCAN^® (naloxone HCl) Nasal Spray as an over-the-counter (OTC) emergency treatment for opioid overdose, marking a historic first. The FDA has granted Priority Review, with a decision expected by March 29, 2023. The move aims to enhance access to NARCAN amid a rising opioid crisis, which saw over 71,000 fatalities from opioids in 2021 alone. Emergent plans to leverage five years of post-marketing data and Human Factors studies to support the application.

Emergent BioSolutions has announced a research award from the U.S. Department of Defense to evaluate the efficacy of its single-dose chikungunya virus vaccine candidate. The collaboration involves the Armed Forces Research Institute of Medical Sciences to conduct a Phase 3b clinical study assessing the vaccine's effectiveness in areas with active chikungunya transmission. The initiative is backed by a $10 million budget for planning and clinical phases, supporting the aim to combat chikungunya, a significant public health threat.

Emergent BioSolutions (NYSE: EBS) reported Q3 2022 financial results, revealing total revenues of $240 million, a decline of 27% compared to Q3 2021. The company faced a net loss of $75.7 million and adjusted EBITDA of $(15.2 million. Product sales fell 31% year-over-year, driven by decreased sales of nasal naloxone and ACAM2000. Despite challenges, the acquisition of TEMBEXA and ongoing clinical trials for vaccine candidates show potential for future growth. The revised 2022 financial outlook projects total revenues between $1.05 billion and $1.1 billion.

Emergent BioSolutions (NYSE:EBS) announced positive Phase 2 results for its chikungunya virus vaccine candidate. The study included 60 healthy adults, showing that the vaccine was well-tolerated and immunogenic in both vaccine-naïve participants and those previously vaccinated against other alphavirus vaccines. Notably, the seroconversion rate was 100% in both groups. The findings were presented at the ASTMH annual meeting, highlighting the potential utility of the vaccine for U.S. military personnel facing heightened exposure risks. Currently, there are no approved vaccines for chikungunya disease.

Emergent BioSolutions (NYSE: EBS) has scheduled a conference call for November 8, 2022, at 5:00 PM ET to review its Q3 2022 financial results, recent business developments, and 2022 financial outlook. Investors can join via webcast or by phone after registering. A replay will be accessible on the company’s investor page. Emergent BioSolutions focuses on defending public health threats through vaccines and therapeutics and aims to enhance the lives of one billion people by 2030.

Emergent BioSolutions (NYSE: EBS) has successfully acquired exclusive worldwide rights to TEMBEXA® (brincidofovir) from Chimerix. The FDA-approved antiviral, indicated for smallpox treatment in all age groups, enhances Emergent's medical countermeasure portfolio. The acquisition follows regulatory approvals, including BARDA's consent for a $680 million contract covering up to 1.7 million treatment courses. Emergent's initial payment is $238 million, with additional milestone and royalty payments based on U.S. and international sales.

Emergent BioSolutions (NYSE: EBS) has commenced dosing the first participant in a Phase 1 clinical trial of EBS-LASV, a VSV-vectored vaccine aimed at combating Lassa virus infections. The study, co-funded by CEPI, will assess the vaccine's safety and immunogenicity in around 36 healthy adults in Ghana. Dr. Kelly Warfield emphasized the company's commitment to addressing public health threats, while CEPI highlighted the urgency of developing solutions against Lassa fever, which currently lacks approved vaccines or treatments.

Emergent BioSolutions (NYSE: EBS) announced participation in several investor conferences in August and September 2022. Key events include the 12th Annual Midwest IDEAS Investor Conference on August 24, a fireside chat at the Wells Fargo 2022 Healthcare Conference and Leveraged Finance Conference on September 8, and the Morgan Stanley 20th Annual Global Healthcare Conference from September 12-14. Webcast presentations will cover recent business developments and financial results, available live and on replay from the Emergent website.

Emergent BioSolutions (NYSE: EBS) reported Q2 2022 results with total revenues of $242.7 million, down 39% year-over-year. Net loss reached $56.4 million, marking a significant decline from the prior year's profit of $4.6 million. Adjusted EBITDA stood at $(28.8) million, down from $49.5 million. The company executed an agreement to acquire TEMBEXA and announced an FDA review of its anthrax vaccine. For 2022, total revenue guidance has been set at $1.15 to $1.25 billion, with CDMO revenues projected at $105 to $125 million.