Emergent BioSolutions Inc.

Good day and thank you for standing by. Welcome to the first quarter 2022 Emergent BioSolutions Earnings Conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone, and if you require any further assistance, please press star 0. I would like to hand the conference over to management. Please go ahead.

Thank you, Victor, and good afternoon, everyone. My name is Bob Burrows, VP and Investor Relations Officer for the company. Thank you for joining us today as we discuss the operational and financial results for first quarter 2022. As is customary, today's call is open to all participants and the call is being recorded and is copyrighted by Emergent BioSolutions. In addition to today's press release, there is a series of slides accompanying this webcast available to all webcast participants. Turning to slide three and four, during today's call, we may make projections and other forward-looking statements related to our business, future events, our prospects, or future performance. These forward-looking statements are based on current intentions, beliefs, and expectations regarding future events. Any forward-looking statement speaks only as of the date of this conference call and except as required by law. We do not undertake to update any forward-looking statement to reflect new information, events, or circumstances. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the SEC when evaluating our forward-looking statements. During today's call, we may also refer to certain non-GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding emergence operating performance. Please refer to the tables found at today's press release regarding our use of adjusted net income, adjusted EBITDA, and adjusted gross margin, and the reconciliations between our GAAP financial measures and these non-GAAP financial measures. Turning to slide five, the agenda for today's call will include Bob Kramer, President and Chief Executive Officer, who will comment on the current state of the company, and Rich Lindahl, Chief Financial Officer, who will speak to the financials for 1Q 2022, which will also discuss the updated 2022 guidance. This will be followed by a Q&A session where additional members of the executive leadership team are present and available as needed. Finally, for the benefit of those who may be listening to the replay of the webcast, this call was held and recorded on April 28, 2022, since Ben Emergent may have made announcements related to topics discussed during today's call. And with that introduction, I would now like to turn the call over to Bob, whose section begins with slide six. Bob?

Thank you, Bob, and good afternoon, and thank you to everyone for joining the call. I'm pleased to share details about our performance and progress in the first quarter. And as Bob indicated, my comments are summarized on slide seven of the deck. The entire team at Emergent remains focused on our strategic vision to grow business carefully by choosing and investing in public health threat markets in which we believe we can make a difference for our patients. Every day we deliver on this promise with a diversified business model and disciplined operating approach that enables us to navigate through uncertain environments such as what we've experienced and been through throughout the COVID-19 pandemic. While our report today reflects a mix of both positive progress and challenges to address, we remain financially strong with the resources to continue pursuing our vision of protecting and enhancing one billion lives by 2030. Our first quarter results are solid. As we hit the upper end of our forecast range for total revenues, and exceeded street consensus estimates for other key performance metrics. Through the first quarter, the output and achievements of the commercial and medical countermeasures business lines is indicative of the strength and resilience of our core products segment. We also continue to advance our R&D pipeline in line with the research and development objectives we shared in the last call. Such investments in R&D are consistent with our view toward development projects as sources of potential future organic growth for the company and possibly for further expansion of our impact on public health preparedness and response. On that point, last week we completed our BLA submission to the FDA for AV7909, our new anthrax vaccine candidate and lead R&D program. We anticipate receiving confirmation from the FDA within 60 days whether our submission has been accepted and the timing of the review. Typically, a priority review would take approximately six months, and a standard review would take up to 10 months from the time of BLA's acceptance. Also, we successfully are enrolling participants in the pivotal phase three clinical trial for a single-dose chikungunya virus VLP vaccine candidate. And also, we initiated a phase one study of cyan, our potential intranasal treatment for cyanide poisoning. With respect to our commercial and medical countermeasures business lines, let me make a couple of comments. First, our nasal naloxone franchise, which includes Narcan nasal spray and the authorized generic licensed to and distributed by Sandoz continues to perform in line with our projections across key customer segments. As we continue to expand access to ensure Narcan is broadly available in the community, millions of doses of our nasal naloxone products were distributed this last quarter. We continue to see demand from our longtime public interest customers in the United States and continued growth in demand in Canada. Also, our medical countermeasures business continues to deliver on long-term contracts with the US and allied governments, and we look to evaluate opportunities in international markets as part of our 2024 strategic plan. I'd like to publicly commend our medical countermeasures team and the work they're doing in light of the war in Ukraine and the potential for intentional or naturally occurring biologic threats as well as chemical threats. The team has been working closely with the United States and allied governments as well as global non-government organizations to identify and mobilize supplies of medical countermeasures. One case in point, we recently received an urgent request from the Ukrainian Ministry of Health that resulted in emergence donation of 200 vials of botulism antitoxin. Additional requests and orders are currently being assessed. The tragedy in Ukraine and the potential threat of biologic or chemical attacks is a reminder of Emergent's critical role in helping prepare the United States and our allies to respond in the event that the unthinkable becomes reality. Let me now turn to the CDMO business. Our non-COVID-related CDMO business continues to show durability. We are retaining current clients and garnering new business across the network of sites. However, as is the case with the rest of the healthcare sector, we're seeing a slowdown in COVID demand as needs wane and we enter a new phase in the pandemic. Johnson & Johnson recently announced that they were suspending guidance related to the sales of their COVID-19 vaccine because of the current oversupply in the market. Given this uncertainty, we are temporarily suspending our CDMO-specific guidance, and Rich will share more on guidance in a moment. We remain in discussions with J&J on their future COVID-19 vaccine needs, and importantly, our contract with them remains in place, as is our commitment to delivering on our obligations under it. In addition, we've made progress with the previously planned modifications and enhancements which are now underway at our Bayview facility. These changes will improve the ability to manufacture viral and non-viral products, as well as strengthen Bayview's offerings for both internal and external clients as part of its planned future role within our CDMO network. We anticipate completing these enhancements in Q3 of this year. As you may recall, Bayview was always intended to be a multi-product facility. We've begun the tech transfer of our Raxi Vacumat product into the facility prior to the pandemic, and the urgent needs of that pandemic put those plans on hold. Before I touch on some personnel updates, I want to take a moment to remember Emergence founder, Fuad Elhibri, who passed away last Saturday. Fuad's entrepreneurial spirit and bold vision serve as the foundation of our company and our mission to protect and enhance life. Our thoughts and prayers go out to his family and friends. On a personnel-related matter, last month we were pleased to announce Jolt Harshiani as the newly appointed chairman of the board of directors and Keith Katkin as a new independent director. Both assume their new roles effective April 1st. We've also recently hired three experienced industry experts to fill key roles on our leadership team. Reinforcing our focus on the culture of quality and compliance, Colleen Glessner joined as the Executive Vice President for Global Quality and Ethics and Compliance, reporting directly to me. Colleen previously worked at Alexion Pharmaceuticals, where she served as Senior Vice President and Chief Quality Officer. Also, Joe Philippos joins us as Senior Vice President and Chief Ethics and Compliance Officer, reporting to Colleen. Joe also previously worked at Alexion and served in the role of VP, U.S., and Enterprise Compliance. And finally, Bill Hartzell joined the team as Senior Vice President and head of the CDMO Business Unit, reporting directly to Adam Havey. Bill came to us from Woodstock Sterile Solutions, where he was chief commercial officer and previously worked for Catalan. As I wrap up and in conclusion, even as market dynamics shift and emergence business evolves, we continue to deliver for our current patients and customers. We continue to make progress advancing our R&D pipeline, and we continue to seek new opportunities to protect and enhance life against public health threats. I look forward to your questions and will now turn the call over to Rich for a deeper look into the financials. Rich?