Emergent BioSolutions Inc. (NYSE:EBS) Q3 2023 Earnings Call Transcript

In September, we shipped hundreds of thousands of boxes to over 32,000 locations, including major pharmacy retailers and e-commerce sites. While expansion of access is critical, so is the need to broaden awareness. To that end, the Emergent proudly launched our Ready to Rescue National Public Awareness campaign in October. Ready to Rescue aims to break down the stigma associated with opioid overdose and educate the public, particularly college age adults, around the risks associated with opioids and how to be prepared with NARCAN Nasal Spray. There is an immense need for NARCAN. We are seeing continued bipartisan support to address the opioid crisis and many prominent public figures have been vocal around the importance of carrying naloxone.

We have ongoing engagement with leaders across government, retail and advocacy groups to increase access and availability of naloxone, as well as educate the public on the risk of opioid overdoses and the real world needs to be prepared with NARCAN Nasal Spray. The over-the-counter launch is a critical advancement of our efforts to expand access, increase awareness and fulfill our mission to protect and enhance lives by saving more lives with NARCAN. With the backdrop of all this, we continue to be well prepared from a manufacturing and supply standpoint to meet the anticipated demand. With that, I will turn it over to Rich.

Rich Lindahl: Thank you, Paul, and good afternoon, everyone. We appreciate you joining the call. I will begin by providing some context for our decision to reschedule today’s earnings release and conference call. You will note that in our press release, we reported limited third quarter and year-to-date results, as well as selected balance sheet and cash flow information. As part of our quarterly review process, the company determined that its state deferred tax liability was overstated as of December 31, 2022, resulting in an understatement of the income tax benefit reflected on the company’s income statement. While these non-cash items do not have any impact on the company’s liquidity, cash flow, historical management compensation or covenant compliance, we have concluded that it is appropriate to delay the disclosure of full third quarter and year-to-date earnings information and the filing of our quarterly report on Form 10-Q for the period ended September 30, 2023, while we work to correct our prior period financial statements.

We expect to complete this work in the near future and accordingly are sharing as much information as we can at this time regarding our current results and financial position. With that, I will move to slide nine and open my remarks with the key messages I’d like you to take away from our call. During Q3, we continued to make progress strengthening the fundamentals of the business. As we announced in August, our key focus going forward will be on the medical countermeasure and NARCAN businesses, while maintaining key commitments to our CDMO customers. There were several highlights in the quarter. As you have just heard from Haywood and Paul, NARCAN OTC hit retail shelves in September and we are excited about the opportunity to expand access to this critical opioid overdose treatment to all individuals.

The overall NARCAN business had strong sales led by the public interest and Canadian channels. In medical countermeasures, procurement was in line with our expectations for Q3. The first shipment of the FDA-approved CYFENDUS was completed in September and the smallpox franchise also had positive sales, primarily driven by VIGIV. Our decision to deemphasize CDMO and focus on our existing customers, supported cost reduction efforts in the third quarter. As previously disclosed, we expect the full annualized run rate of these actions will exceed $100 million of reduced costs across the organization beginning in the first quarter of 2024. Overall, we had strong revenue in the quarter, which exceeded our guidance range. Adjusted EBITDA was also solid in the quarter, slightly exceeding our expectations.

I’d like to take a moment to highlight that our Camden facility warning letter was closed out by the FDA after acknowledgment of the extensive remediation efforts completed since August 2022. This positive development is a testament to the dedication and skill of our quality and operations teams, and position the facility to return to normal operations as we support our existing customers going forward. We have updated our 2023 guidance to reflect our expectations for the rest of this year. A key driver is the continued momentum in NARCAN sales as our public interest Canadian and now retail over-the-counter customers seek increased preparedness for the threat of opioid overdoses. On the medical countermeasures side, our sales forecast remains largely intact with some uncertainty regarding the timing of U.S. Government funding for the remaining 2023 CYFENDUS procurement.