Emergent Biosolutions, Inc. - EBS STOCK NEWS

Emergent BioSolutions (NYSE:EBS) announced that two batches of its COVID-19 vaccine have received FDA authorization for emergency use, produced at the Bayview facility. The company is actively working with the FDA to address previous observations and aims to resume production soon. Emergent's Bayview facility, designated as a Center for Innovation in Advanced Development and Manufacturing, has been crucial for COVID-19 vaccine readiness since mid-2020. However, the company acknowledges the challenges of timely and sufficient vaccine production.

Emergent BioSolutions reported promising two-year data from its Phase 2 clinical trial for the chikungunya virus VLP vaccine, demonstrating a significant immune response. The study involved 415 healthy adults, showing that the SNA mean titers were 19 times higher than pre-vaccination levels after a single 40 µg dose. The vaccine was well-tolerated, with mostly mild side effects. All participants remained seropositive at one and two years post-vaccination. This data supports moving to a Phase 3 trial aimed at addressing the unmet need for chikungunya vaccination.

Emergent BioSolutions (NYSE: EBS) will host its 2021 Annual Meeting of Stockholders as a virtual-only event on May 20, 2021, at 9:00 AM EDT. Eligible stockholders can participate by accessing the meeting online at www.virtualshareholdermeeting.com/EBS2021 using their unique Control Number. Guests can attend in listen-only mode without voting rights. The company encourages participants to log in 15 minutes early. A replay of the event will be available on Emergent's website.

Emergent BioSolutions (NYSE: EBS) announced participation in upcoming investor conferences. The company will hold 1-on-1 meetings at the Goldman Sachs Credit and Leveraged Finance Conference on May 17, 2021, and at the Benchmark Company Healthcare House Call Conference on May 26, 2021. Additionally, a company presentation is scheduled during the Singular Research Spring Select Webcall on May 27, 2021, at 8:00 am Pacific / 11:00 am Eastern. Webcast presentations will discuss recent business developments and financial results, accessible live and via replay on the Emergent website.

Emergent BioSolutions (EBS) reported Q1 2021 financial results with total revenues of $343.0 million, an 78% increase from Q1 2020. The net income was $69.7 million, compared to a loss of $12.5 million in Q1 2020. Adjusted EBITDA rose to $123.5 million, up from $15.3 million. Product sales decreased by 7% to $137.9 million, primarily due to lower sales of certain products. Revenue from contract development and manufacturing services surged to $183.8 million, attributed to partnerships addressing COVID-19. The company revised its 2021 revenue forecast to $1.7 - $1.9 billion.

The FDA has completed its inspection of Emergent BioSolutions' Baltimore-Bayview facility, providing specific feedback to enhance operations. Emergent is committed to collaborating with the FDA and Johnson & Johnson to address identified issues promptly. While acknowledging the shortcomings, the company expresses confidence in rectifying them quickly, emphasizing its workforce's dedication to producing high-quality COVID-19 vaccines. The press release highlights the importance of maintaining strong relationships with manufacturing partners and outlines the specific steps necessary for operational improvements.

Emergent BioSolutions (NYSE: EBS) will hold a conference call on April 29, 2021, at 5:00 PM ET to discuss its Q1 2021 financial results and revenue guidance for Q2 and the full year 2021. The call will cover recent business developments and provide insights into the company's financial outlook. Investors can join via telephone or webcast. For more details and to access the replay, visit the Emergent website.

Entwistle & Cappucci LLP is investigating Emergent BioSolutions (NYSE: EBS) for potential federal securities law violations. The inquiry follows the contamination of 15 million doses of Johnson & Johnson's COVID-19 vaccine and Emergent's failure to address known manufacturing quality issues. Despite producing approximately 150 million vaccine doses, many remain unusable due to FDA compliance failures. Following the news, Emergent's stock dropped 13.4%, equating to a $590 million loss in market capitalization.

Emergent BioSolutions (EBS) has received a $23 million increase in its task order from HHS for additional biologics manufacturing equipment. This funding is aimed at supporting Johnson & Johnson’s COVID-19 vaccine production, specifically enhancing manufacturing capabilities at the Baltimore Bayview facility.

The company reaffirms its 2021 financial guidance and reports no changes to its manufacturing agreements related to COVID-19 vaccines. Emergent is committed to strengthening the supply chain for Johnson & Johnson’s vaccine, with an annual production capacity exceeding one billion doses.