NYSE:EBS Emergent BioSolutions Q4 2024 Earnings Report $4.60 -0.03 (-0.65%) As of 02:10 PM Eastern Earnings HistoryForecast Emergent BioSolutions EPS ResultsActual EPS$0.05Consensus EPS -$0.35Beat/MissBeat by +$0.40One Year Ago EPS-$0.77Emergent BioSolutions Revenue ResultsActual Revenue$194.70 millionExpected Revenue$254.67 millionBeat/MissMissed by -$59.97 millionYoY Revenue GrowthN/AEmergent BioSolutions Announcement DetailsQuarterQ4 2024Date3/3/2025TimeAfter Market ClosesConference Call DateMonday, March 3, 2025Conference Call Time5:00PM ETUpcoming EarningsEmergent BioSolutions' Q1 2025 earnings is scheduled for Tuesday, April 29, 2025, with a conference call scheduled on Wednesday, April 30, 2025 at 5:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Emergent BioSolutions Q4 2024 Earnings Call TranscriptProvided by QuartrMarch 3, 2025 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Good day and thank you for standing by. Welcome to Emergent BioSolutions Inc. Fourth Quarter twenty twenty four Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Operator00:00:22Please note that today's conference is being recorded. I would now like to turn the call over to Frank Fargo, PPE Assistant Treasurer. Please go ahead. Speaker 100:00:31Good afternoon, everyone. Thank you for joining today as Emergent discusses their operational and financial results for the fourth quarter and full year of 2024. 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 two. Speaker 100:00:57During today's call, Emergent may make projections and other forward looking statements related to their business, future events, their prospects or future performance. These forward looking statements are based on their current intentions, beliefs and expectations regarding future events. Any forward looking statement speaks only as of the date of this conference call and as required by law, Immersion does not undertake to update any forward looking statements to reflect new information, events or circumstances. Investors should consider this cautionary statement as well as the risk factors identified in Emergent's periodic reports filed with the SEC when evaluating their forward looking statements. During today's call, Emergent may also discuss certain non GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding Emergent's operating performance. Speaker 100:01:47Please refer to the tables found in today's press release. Turning to Slide three. The agenda for today's call will include Joe Papa, President and Chief Executive Officer, who will comment on our multi year transformation progress and Rich Lindahl, EVP and Chief Financial Officer, who will speak to the financials for the fourth quarter and full year 2024, as well as provide full year guidance for 2025. Joe Papa will conclude by discussing the 2025 business outlook and key growth drivers followed by Q and A. Finally, for the benefit of those who may be listening to the replay of this webcast, this call was held and recorded on 03/03/2025. Speaker 100:02:26Since then, Emergent may have made announcements related to topics discussed during today's call. And with that, I would now like to turn the call over to Joe Papa for opening remarks. Joe? Speaker 200:02:36Thank you, Frank. Hello, everyone, and thank you for joining us to discuss our fourth quarter and full year twenty twenty four earnings. I'm joined today by Rich Lindell, our Chief Financial Officer. I'm pleased to be here today to share with you updates on our business, including our contributions to protecting public health, as well as the opportunities in front of us. Following my opening remarks, Rich will detail our fourth quarter and full year 2024 results as well as provide twenty twenty five full year guidance. Speaker 200:03:06I will close the call with discussion of our business outlook and our path forward into 2025 as we look ahead to continue the significant progress on our turnaround efforts. Then we'll open up the call for Q and A. I'll now begin on Slide five. I joined Emergent and this leadership team one year ago to turn around the business and focus on our company's mission to protect and save lives. For more than twenty five years, Emergent has responded to solutions to complex and urgent public health threats with preparedness efforts and active responses. Speaker 200:03:38However, the company needed to reduce its debt, improve profitability and pursue future growth at a rapidly evolving landscape. Turning to Slide six, our team immediately went to work developing and implementing a multiyear transformational plan to stabilize, turnaround and ultimately transform the emerging business. Executing on this plan required making difficult, but necessary decisions, including divesting sites and assets to improve our profitability. Through the great efforts of the entire team, we completed our first phase of plan, the stabilization phase, marked by a reduction in debt, a stronger balance sheet and a renewed focus on our mission. We are delighted to have completed this first phase ahead of schedule. Speaker 200:04:25In 2025, we'll be executing our turnaround phase and transforming the company to generate long term profitable growth. On Slide seven, we highlight our important accomplishments since we reported fiscal year twenty twenty three results last year. In 2024, we dramatically improved our financial position. This we believe gives us operating flexibility and the ability to focus on driving growth. Among those key actions, we delivered on our plan to stabilize the company and secure commitments, including reducing net debt, refinancing and extending the debt maturity to 2029. Speaker 200:05:03We improved profitability and operating cash flow. We strategically divested assets and streamlined our site network, while meeting internal product delivery commitments for customers and significantly improving operating margins. We reduced operating expenditures by $130,000,000 while delivering on our core product commitments. We refocused our core business segments to medical countermeasures in NARCAN nasal spray. Of note, we have continued to combat the opioid epidemic with NARCAN nasal spray. Speaker 200:05:34And in 2024, we distributed 11,000,002 dose cartons or 22,000,000 doses across The U. S. And Canada. We continue to be the market leader in a growing Naloxone nasal spray market. We've been on the front line supporting public health preparedness with The U. Speaker 200:05:51S. And other allied government customers to address threats like anthrax, smallpox, mPox and botulism and secured five fifty million dollars in MCM contract awards. And lastly, we resolved legacy legal and quality issues and improved our quality and compliance systems companywide. I want to underscore that we treat critical stabilization priority while ensuring the highest standards of patient safety, quality and compliance. Progressing to Slide eight, our success in 2024 allows us to focus on the following five key critical areas and goals for our 2025 plan: strong profit follow through from 2024 with a focus on higher net income, increased gross margin percentage and an increased adjusted EBITDA margin percentage Operating cash flow growth versus 2024 and strong positive free cash flow. Speaker 200:06:46Rebuilding our product pipeline, our CMO and Head of R and D, Doctor. Simon Lowry will be driving these efforts. Further optimization of manufacturing operations in partnership, potentially taking additional steps to streamline our manufacturing footprint. And lastly, strategic capital deployment for opportunistic growth through business development. These will be the right size investments that we see clear value and potential to harness our expertise and capabilities similar to our Cloxado business development transaction. Speaker 200:07:19Before handing to Rich, for a more detailed financial review, I'd like to set the stage for our 2025 guidance. We view guidance as a commitment to our stakeholders. Heading into 2025, we believe there are dynamics and factors that lead us to take a more conservative approach to guidance. The onboarding of a new administration may cause shifts in the timing of product deliveries or may cause uncertainty due to staff transitions. Over the course of more than twenty five years serving and partnering with government customers, we are very familiar with the gap between ships. Speaker 200:07:51Our products are mission critical, a belief and an understanding we believe that has been shared by many administrations and today enjoy bipartisan support for the importance of biodefense and decreasing opioid overdose deaths. Notwithstanding our conservative full year guidance, we believe we will have a strong first quarter. As standard practice, we plan to update our guidance every quarter as we have in the past years. Following Rich's comments, I'll spend some time elaborating on these areas. I'll now hand the call over to Rich. Speaker 100:08:23Thank you, Joe. Good afternoon, everyone. We appreciate you joining the call. Over the course of 2024, we made significant progress stabilizing the financial foundation of the business and have moved into the turnaround phase of our multi year transformational plan. Our unique set of medical countermeasure and opioid overdose reversal products provides life saving capabilities to people around the world, drives sustainable revenue over time and garners bipartisan support. Speaker 100:08:51And we believe the actions we have taken over the past two years have brought us to an inflection point in profitability and cash flow that will enable us to identify and pursue value creating growth opportunities as we move forward from here. Joe will have more to say about our vision after I run through the numbers. Our fourth quarter results were broadly in line with the guidance we provided on our third quarter call. Our key financial metrics are summarized on Slide 10. Total revenues of $195,000,000 down versus the prior year as lower NARCAN sales and anthrax sales timing were partially offset by higher smallpox sales. Speaker 100:09:27Adjusted EBITDA of $21,000,000 an increase of $18,000,000 versus the prior year. Total segment adjusted gross margin of 40% improved 800 basis points year over year as a result of product mix, as well as an improved cost structure stemming from our previously announced restructuring efforts. And a total reduction of $49,000,000 or 41% in operating expenses across R and D and SG and A versus the prior year. Of note, these expense levels now represent a dollar run rate that incorporates the full impact of our cost savings efforts. Transitioning to Slide 11 and our strong full year results, total revenues were $1,040,000,000 roughly flat versus the prior year. Speaker 100:10:12Total adjusted EBITDA of $183,000,000 which is a $2.00 $5,000,000 positive swing versus the negative $22,000,000 in 2023. Total adjusted gross margin of $457,000,000 an annual improvement of $121,000,000 or 1,200 basis points as a percentage of revenue. Full year operating expense of $379,000,000 was down $101,000,000 or 21% year over year with reductions in both R and D and SG and A driven by the cost actions taken in the second half of twenty twenty four. Moving to Slide 12, our full year revenue highlights were total product sales of $9.00 $9,000,000 a slight decline versus the prior year as increased smallpox revenue from both the U. S. Speaker 100:11:00Government and international customers was offset by lower NARCAN sales and the timing of anthrax sales. Within NARCAN, we continue to remain competitive on price and focused on our competitive advantages, including our brand recognition, market leading distribution capabilities and customer service. Full year volume was strong with 2024 levels consistent with 2023. Prices lower compared to 2023, but has stabilized in the back half of 2024. Total bioservices revenue of $105,000,000 represents an improvement year over year of $26,000,000 driven by the $50,000,000 1 time settlement agreement with Janssen. Speaker 100:11:42And finally, contracting grant revenue was $30,000,000 for 2024, primarily from the continued U. S. Government funding of the Yubonga program for treatment of Ebola. On Slide 13, we recap the material achievements that we accomplished ahead of expectations in 2024. We completed $117,000,000 of asset sales and received a $50,000,000 payment from Janssen Pharmaceuticals as a result of the confidential settlement agreement. Speaker 100:12:08We improved the overall cost structure with actions producing $130,000,000 of annualized savings in 2024. This brings the total operating expense savings to a $250,000,000 over the last two years, while maintaining capabilities across our core product portfolio. We also received $30,000,000 in development milestone payments from Bavarian Nordic. These key liquidity enhancements supported the refinancing of our prior secured credit facility as we entered into a new $250,000,000 term loan from Oak Hill Advisors, extending the maturity of our debt to August 2029. And we closed a $100,000,000 asset backed revolving credit facility led by Wells Fargo, also maturing in 2029. Speaker 100:12:53On Slide 14, we highlight the significant improvements to our financial metrics. At the end of twenty twenty four, we had total liquidity of $200,000,000 comprised of $100,000,000 of cash and $100,000,000 of undrawn revolver capacity. This outcome was aided by generating $59,000,000 of operating cash flow, an improvement of $265,000,000 year over year. As a result of refinancing our debt and the improved cash position, net debt at year end was $6.00 $1,000,000 a $156,000,000 or twenty one percent reduction since the beginning of 2024. This outcome coupled with the strong performance in the business materially lowered our net leverage to 3.3 times adjusted EBITDA. Speaker 100:13:36The credit rating agencies have also recognized the improved financial position of the company. Moody's and S and P both upgraded our corporate family credit rating to B3 and B- respectively with stable outlooks. I will also note that the prior going concern qualification has been removed from the audit opinion and financial disclosures that will be in our 10 K filing. Transitioning to Slide 15, it's important to note it's important to point out that total 2024 revenue of $1,040,000,000 includes approximately $115,000,000 that is no longer in the base as we begin 2025. First, the Janssen settlement agreement resulted in recognition of 50,000,000 of revenue in our bioservices business. Speaker 100:14:21And RSDL and Camden combined generated approximately $65,000,000 of revenue prior to their divestiture in the third quarter of twenty twenty four. Accordingly, as a starting point for 2025, the normalized 2024 revenue was roughly $930,000,000 With that backdrop, please turn to Slide 16 for full year 2025 guidance. Our total revenue guidance for 2025 is $750,000,000 to $850,000,000 As a reminder, Joe noted that we are being conservative due to the transitions anticipated in the new administration. We are forecasting 2025 adjusted EBITDA of $150,000,000 to $200,000,000 The midpoint is approximately consistent with 2024 full year results even in light of the lower revenue guidance. This highlights our significant efforts to improve the go forward cost structure and profitability of the business. Speaker 100:15:13We believe that this year may represent a trough in adjusted EBITDA going forward as we expect to grow our profitability from here. We're also anticipating a return to positive bottom line earnings. We forecast a range of net income from $16,000,000 to $66,000,000 and a range of adjusted net income from $20,000,000 to $70,000,000 For the full year of 2025, we're forecasting total segment adjusted gross margin of 48% to 51%, roughly a 500 basis point expansion at the midpoint versus 2024 results aided by our leaner and more focused manufacturing footprint. Moving to segment level revenue guidance, we're forecasting MCM product sales of $435,000,000 to $485,000,000 across U. S. Speaker 100:15:59Government and international orders. And we estimate a range of $265,000,000 to $315,000,000 in our commercial products, which includes both NARCAN and Cloxado. As part of this guidance, we expect NARCAN to continue to maintain a leading market share of the growing total addressable naloxone nasal spray market. And for the first quarter of twenty twenty five, we're forecasting a total revenue range of $200,000,000 to $240,000,000 which is a strong and healthy start to the year. In closing on Slide 17, we've entered the turnaround phase of our multi year plan ahead of schedule. Speaker 100:16:35We are anticipating strong profit follow through from 2024 even with lower top line revenue, which we are focused on improving from here. Our guidance therefore implies a very strong margin improvement story, which in combination with our expectations for continued positive operating cash flow and anticipated Bavarian Nordic milestone payments in 2025 positions us to capitalize on growth opportunities for the business as we move forward. For more on that, I'll now turn the call back over to Joe. Speaker 200:17:05Thank you, Rich. Turning to Slide 19, I'd like to provide context around the financials and our business outlook for 2025. Our mission to protect and save lives from opioid overdose is evident in the work we do to increase access, awareness and the availability over the counter NARCAN. NARCAN remains the market leader amongst intranasal naloxone products with an approximately 75% share of the market. We believe our continuous leadership and work to expand OTC access to NARCAN is a key contributor to the declining national rate of opioid overdose death recently reported by the CDC. Speaker 200:17:42But while this preliminary data points the first meaningful decline in opioid overdose deaths in years, we are still seeing the devastating effects of opioid overdose. Tragically, rates of opioid overdose remain high in Canada, especially in British Columbia, Ontario, Alberta Speaker 300:18:00and the indigenous communities. Speaker 200:18:02In The U. S, the public interest channel is backed by over $50,000,000,000 in opioid settlement funds from large pharma companies that are expected to flow through over the next ten to fifteen years and another $3,500,000,000 in federal grants supporting Nalaxone access in 2025. This funding remains critical as there are still an unacceptable number of opioid overdoses and deaths caused by fentanyl. I'd like to review the critical element that underpin our NARCAN franchise as we work to continue reducing opioid overdose deaths in 2025. The NARCAN nasal spray value drivers continue to support a differentiated and competitive price point for our customers. Speaker 200:18:46We expect to maintain market share leadership and anticipate the total Natlaxone market unit volume will grow by mid to high single digit rates. We are expanding reach into businesses and one important aspect of this work is our commercial engagement with the National Safety Council. We are starting to make headway to several major companies that are prioritizing first aid safety kits with OTC NARCAN. Our hope is that someday every first aid kit in The U. S. Speaker 200:19:18And Canada will include a box of NARCAN nasal spray. We've built a national logistics network, NARCAN Direct, which serves 18,000 different endpoints for public interest customers. This program allows them to get the product volumes that they need when they need it. We believe today that no other company has the capability and no one can match our NARCAN nasal spray production capacity. As we announced in January, we secured commercial rights for product sales and marketing in U. Speaker 200:19:50S. And Canada to cloxidil nasal spray from Hikma. This additional solution helps expand Emergent's ability to distribute multiple life saving opioid overdose emergency treatments to patients, customers and communities in need. In summary, we believe NARCAN is the standard of care and plays an important role in reducing the number of overdoses that result in death. And given Emergent's proven track record of supplying NARCAN nasal spray to states, first responders, law enforcement, community groups and other organizations, adding Cloxado nasal spray provides customers with the flexibility to tailor their treatment for specific patients. Speaker 200:20:33Moving to Slide 20, our MCM business, it's worth noting. We're continuing to provide essential biodefense services for an increasingly dangerous world that we live in, where bioterror threats are constant and at the same time ever changing. The four key priority threats for the administration for strategic preparedness and response are anthrax, smallpox, Ebola and botulism. And there are aligned the key focal points of our MCM portfolio. We believe biodefense portfolio is well positioned with visibility into future recurrence based on our long term contracts. Speaker 200:21:13As a reminder, we received $550,000,000 in biodefense contract modifications in 2024. It is also important to note that Department of Defense has a mandatory funding obligation for BioThrax, which is a pre and post exposure anthrax vaccine from military personnel. We see opportunities to continue playing active part in addressing the ongoing m pox outbreak with AGM2000. We're also enthusiastic about the potential of our other MCN products, including Tempexa and Evanga and their ability to contribute to future growth. We have a U. Speaker 200:21:51S. Government funding committed through 2027 for Temvexa, which further demonstrates our MCM assets are important for biodefense. Moving to Slide 21 with respect to important catalyst to enable growth in 2025, we are looking forward to the ACAM2000 emergency use lifting with the World Health Organization as the MPOS public health upgrade continues to evolve. We remain focused on revenue diversification within our existing businesses and improving our core capabilities to drive revenue growth. This includes opportunities to drive growth such as the anticipated incremental revenue to be generated by Cloxado Nasal Spray. Speaker 200:22:33At the same time, we will be looking internationally for growth opportunities across our product portfolio. I'd like to note that we're also anticipating $50,000,000 of Bavarian Nordic chikungunya vaccine approval milestone payments starting in the next thirty days. As we execute on our 2025 turnaround initiative, we will strive for the highest standard for quality, ethics and compliance. In closing, for all the reasons we have discussed, we believe Emergent is poised for a significant turnaround opportunity that we believe will lead to profitable and sustained growth. And with that, I look forward to taking your questions. Speaker 200:23:11Operator, if you could open the lines for your questions, please. Operator00:23:28Our first question coming from the line of Jessica Fye with JPMorgan. Your line is now open. Speaker 400:23:36Hey, this is Nick on for Jess. Thanks for taking your questions. First, on your NARCAN guidance, can you just provide a bit more specifics on the underlying assumptions around maybe volume and price? I think you say that you expect growth for the overall market and while you expect to maintain leading share in that market. Can you just comment on how that's broken down in the pit market versus other channels? Speaker 400:23:57Just how much share you expect in 2025 relative to 2024? And any guidance on maybe additional pricing pressure in that market? Speaker 200:24:08Sure. Try to take the first part of it and go and I'll just fill in some other parts, but go ahead. Okay. Speaker 100:24:13All right. Thanks, Nick. Appreciate the question. So we've talked about on our last call how the pricing in the first half versus the second half was differential, but that we had seen stabilization in the pricing in the second half. We've broadly seen that continue as we've come into this year. Speaker 100:24:33Having said that, we do expect there to be a follow through impact of that reduction in pricing that we saw in the second half to impact the full year results. I would say that is the biggest driver of the guidance as we go forward into 2025. We have put a fairly wide range to reflect a range of outcomes. We think it's a fairly conservative range and we'll certainly update that as we go through the year. We do continue to anticipate that we'll maintain a very strong and certainly majority market share of the pit market as we go forward. Speaker 100:25:10And I think that's those are the comments that we'll make at Speaker 200:25:14this point. Sure. Maybe just yes, one of the points public interest, I think, is about 75% of our total business, I think, was one of the questions we had inserted in there as well, but I think Richard answered everything else. Speaker 400:25:27Great. And then maybe on yes, just one more. You guys are guiding to adjusted EBITDA in 2025, that's roughly flat year over year at the midpoint. I know you kind of commented on 2025 guidance, you're kind of representing a trough, but how are you thinking about that evolving maybe in 2026 plus on a magnitude basis? And how sensitive is that to the NARCAN dynamics that you're seeing? Speaker 200:25:55Yes. Well, I think one of the things we're doing now as we think about the businesses, we have a diversified business where you've got a number of different assets, obviously with medical countermeasures in NARCAN and now Clapsodo. And as I think Rich mentioned, I mentioned that we continue to look to do some additional business development opportunities in 2025 and beyond. So I think it's really those all of those that will contribute to the overall growth, there are opportunities for growth in our adjusted EBITDA. Obviously, we're not going to say anything specifically about the 2026 yet, but I think it's going to be diversification of our portfolio, the additional organic opportunities we have with what we're doing with Tempexa, what we are doing with the EBONGA for Ebola, what we're doing for the MPOX opportunity. Speaker 200:26:43We did not build MPOX into our 2025 guidance at this time, but we obviously are looking to continue to extend that. That would be an upside for us if we're we're fortunate enough to get that business. So those are all the things that we think will help drive the internal opportunities for 2026. Obviously, on the external business development side, we've got certainly ClogSado and then what other types of business development deals we can do for the future with other companies that are either working in the area of the biodefense medical countermeasures or companies that are working with products for first responders. Those will be the two main avenues which we will pursue for additional business development. Speaker 200:27:26But that would be the probably the main things I'd add to the 2026 question. Speaker 400:27:32Great. Thank you. Speaker 200:27:33Operator, let's take our next question please. Operator00:27:37Thank you. Our next question coming from the line of Brandon Folkes with Rodman and Renshaw. Your line is now open. Speaker 300:27:44Hi. Thanks for taking my questions and I appreciate all the color. Sorry to stick on the 2026 theme here, but I think it's just important. Can you just talk about sort of the SG and A OpEx, sorry not SG and A, but the broader OpEx footprint in your guidance for 2025? How do you think about that sort of beyond 2025? Speaker 100:28:09Yes. I think as I commented on the call, I think as we came out of the fourth quarter, we've got the full benefit of the actions that we've taken in the run rate for the fourth quarter. I think we'll stay focused on continuing to scale the SG and A footprint along with the business as we grow revenue. So I think that there will be opportunities for us to look for additional efficiency improvements on SG and A. Speaker 200:28:34And I think you're seeing that and what Rich was saying, but as you look at what's happening with everything from the gross adjusted gross margin, just overall margins that we're expecting when you do like an operating reduction. So I think all those are packaged together as how we're looking at the expenses we've been taking out of the business in 2023 and 2024 and now we're seeing the full year benefit of it in 2025. Speaker 300:28:59Great. Thanks. And maybe just coming back to KLAXADA, if I said that correctly. How are you going to position that relative to NACA? I know you mentioned sort of now that you own it, some there are some users of it. Speaker 300:29:14I can see it obviously plugging into your distribution system. But do you expect to grow Clixado by sort of positioning it in any way or really being a distribution driven growth story? Speaker 200:29:29First and foremost, when we acquired Cloxado, we made the comment that we think Cloxado is a great opportunity to leverage the platform we have today, for example, with NARCAN Direct programs. Will make it easier for first responders to get access to the product by making it work through our NARCAN Direct distribution capability. So first and foremost, we think it's going to be easier to do business as we put together CLXADA with NARCAN N into our distribution capabilities. Number two, I think as you know and people you read in the news, there are increasing number of fentanyl overdose or fentanyl is causing an increased percentage of the overdoses out there. We think Cloxado may be appropriate for some of those increased fentanyl dosages that are out there in the marketplace. Speaker 200:30:20We want to make sure that if needed, we have Cloxado. If needed, we have a standard of care with NARCAN. Either way, the first responder goes, we think we have the capability to make it easier for them to get what they need for their for the patients and the individuals throughout their treating. So look to us to really just leverage our current distribution and capability with our sales force and put our one more product in their hands to help all of our customers with it. So that's the primary way we'll do it. Speaker 200:30:52Average individual first responders are always going to have to make the judgment as to whether or not they need a four milligram or an eight milligram. We believe that four milligram is the standard of care, but there is an increasing need for eight milligrams and we're glad to have that capability now with the Cloxado transaction. Speaker 300:31:11Great. Thank you very much. Speaker 100:31:13Thank you. Speaker 200:31:14Operator, next question please. Operator00:31:17Our next question coming from the line of Raghuram Saldan Raju with H. C. Wainwright. Your line is now open. Speaker 500:31:27Hi. This is Eduardo on for Ram from H. C. Wainwright. I guess I was I guess we're talking about Quixado. Speaker 500:31:34I wanted to ask, just confirming that it's already available within the NARCAN Direct system and if not, when do you expect that to happen? Speaker 200:31:43Yes. So we announced the transaction in January and now we're working through all the logistics there currently. Obviously, Hikma had some product in the system already. So we're working through all the logistics now and we expect to have it in the next thirty to sixty days is when we'll have it going through our ordering capabilities. But you obviously want to make it easy for the first responders for them to order it to work through our system. Speaker 200:32:07So we're working through all those details to ensure that it's easier for the first responders to get the product and make it a value add for them, not make it a difficult process. So look to us that have more to say about that in the next thirty to sixty days. Speaker 500:32:23Got it. That's really helpful. And just pivoting towards MPoX, just curious if the MOSA trial is still on track for its first interim analysis during the end of this first quarter? Speaker 200:32:39So what we're doing with mPox is we're working with World Health Organization specifically to get the emergency use label. We expect to hear more from them sometime in the near future. Obviously, as we go through changes in administration, changes in policy, we're working through all the questions there, but we'll just have more to say about that specifically as we get feedback from the World Health Organization. Specific to additional clinical trial work, we're doing that clinical trial work, especially with IMVEXXA and with looking to get additional data on our ACAM product. That's not something specifically that we're going to talk too much about right now, but we do have additional clinical trials under work in the small underway in the smallpox area. Speaker 500:33:33Understood. Thanks. And I guess one last one regarding other MCM. Do you have any or do you expect any further near term contract adjustments or option exercises under procurement orders for the biodefense products? And if so, which ones? Speaker 100:33:51Yes. This is Rich, Eduardo. I think what you should expect is that kind of the pattern that was followed in 2024 is a good marker for what is likely to happen in 2025. The timing of specific option exercises could shift from one quarter to another, but broadly speaking, we expect that the U. S. Speaker 100:34:13Government is going to continue to execute against those contracts and issue us procurement orders as we go through the year. Speaker 200:34:20And the only thing I'd add to what Rich said is once again, he said in his own comments during the call, but I think we expect a strong first quarter as a result of the activities we had in 2024. Just really the momentum we had exiting 2024 is going to allow us to have a very strong first quarter, which we obviously think is a great way to start the New Year. Speaker 500:34:42Great. Thanks so much for the clarity. Operator00:34:47Thank you. And I'm showing no further questions in the queue. I will now turn the call back over to Mr. Joe Papa for any closing remarks. Speaker 200:34:55Thank you, operator. Thank you, everyone, for joining us, ladies and gentlemen. We appreciate everyone's attention to our earnings call today. Thank you for your participation. Please note an archived version of today's webcast as well as PDF version of our slides used today will be available on our website accessible through in the Investors landing page on the company website. Speaker 200:35:16Thank you again for joining us. We look forward to speaking with all of you in the near future. Have a great day. Operator00:35:22This concludes today's conference call. Thank you for your participation and you may now disconnect.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallEmergent BioSolutions Q4 202400:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsSlide DeckPress Release(8-K)Annual report(10-K) Emergent BioSolutions Earnings HeadlinesEmergent BioSolutions rises 11.8%April 2, 2025 | markets.businessinsider.comEmergent BioSolutions announces $50M stock repurchase programApril 1, 2025 | markets.businessinsider.comFeds Just Admitted It—They Can Take Your CashThe Government Just Said Your Money Isn't Yours That's right—According to the DOJ, YOUR hard-earned money isn't legally yours. Now, think your savings are safe? Think again.April 16, 2025 | Priority Gold (Ad)Emergent BioSolutions rises 9.0%April 1, 2025 | markets.businessinsider.comEmergent BioSolutions Announces Stock Repurchase ProgramMarch 31, 2025 | globenewswire.comEmergent BioSolutions: I See Further Downside Ahead In This Value TrapMarch 26, 2025 | seekingalpha.comSee More Emergent BioSolutions Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Emergent BioSolutions? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Emergent BioSolutions and other key companies, straight to your email. Email Address About Emergent BioSolutionsEmergent BioSolutions (NYSE:EBS), a life sciences company, provides preparedness and response solutions for accidental, deliberate, and naturally occurring public health threats in the United States. The company offers NARCAN Nasal Spray for the emergency treatment of known or suspected opioid overdose; Vaxchora vaccine for the prevention of cholera; Vivotif vaccine for oral administration for the prevention of typhoid fever; Anthrasil for the treatment of inhalational anthrax; BioThrax, an anthrax vaccine; CYFENDUS for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis; and Raxibacumab injection for the treatment and prophylaxis of inhalational anthrax. It also provides ACAM2000, a smallpox vaccine; CNJ-016 to address complications from smallpox vaccination; TEMBEXA for the treatment of smallpox disease caused by variola virus in adult and pediatric patients; BAT for the treatment of symptomatic botulism; Ebanga for the treatment of Ebola; Reactive Skin Decontamination Lotion Kit to remove or neutralize chemical warfare agents from the skin; Trobigard, a atropine sulfate obidoxime chloride auto-injector. In addition, the company is developing CGRD-001 for the treatment of poisoning by organophosphorus nerve agents or organophosphorus compounds; EBS-LASV to prevent Lassa fever; EBS-MARV to prevent Marburg virus disease; EBS-SUDV to prevent Sudan virus disease; Pan-Ebola mAbs for the treatment of ebola virus; SIAN Antidote for initial treatment of certain or suspected acute cyanide poisoning; UniFlu for immunity against influenza A and B viruses; and WEVEE-VLP for equine encephalitis virus infections. Further, it provides contract development and manufacturing services comprising drug substance and product manufacturing, and packaging, as well as technology transfer, process, and analytical development services. The company was incorporated in 1998 and is headquartered in Gaithersburg, Maryland.View Emergent BioSolutions ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Tesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? 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There are 6 speakers on the call. Operator00:00:00Good day and thank you for standing by. Welcome to Emergent BioSolutions Inc. Fourth Quarter twenty twenty four Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Operator00:00:22Please note that today's conference is being recorded. I would now like to turn the call over to Frank Fargo, PPE Assistant Treasurer. Please go ahead. Speaker 100:00:31Good afternoon, everyone. Thank you for joining today as Emergent discusses their operational and financial results for the fourth quarter and full year of 2024. 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 two. Speaker 100:00:57During today's call, Emergent may make projections and other forward looking statements related to their business, future events, their prospects or future performance. These forward looking statements are based on their current intentions, beliefs and expectations regarding future events. Any forward looking statement speaks only as of the date of this conference call and as required by law, Immersion does not undertake to update any forward looking statements to reflect new information, events or circumstances. Investors should consider this cautionary statement as well as the risk factors identified in Emergent's periodic reports filed with the SEC when evaluating their forward looking statements. During today's call, Emergent may also discuss certain non GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding Emergent's operating performance. Speaker 100:01:47Please refer to the tables found in today's press release. Turning to Slide three. The agenda for today's call will include Joe Papa, President and Chief Executive Officer, who will comment on our multi year transformation progress and Rich Lindahl, EVP and Chief Financial Officer, who will speak to the financials for the fourth quarter and full year 2024, as well as provide full year guidance for 2025. Joe Papa will conclude by discussing the 2025 business outlook and key growth drivers followed by Q and A. Finally, for the benefit of those who may be listening to the replay of this webcast, this call was held and recorded on 03/03/2025. Speaker 100:02:26Since then, Emergent may have made announcements related to topics discussed during today's call. And with that, I would now like to turn the call over to Joe Papa for opening remarks. Joe? Speaker 200:02:36Thank you, Frank. Hello, everyone, and thank you for joining us to discuss our fourth quarter and full year twenty twenty four earnings. I'm joined today by Rich Lindell, our Chief Financial Officer. I'm pleased to be here today to share with you updates on our business, including our contributions to protecting public health, as well as the opportunities in front of us. Following my opening remarks, Rich will detail our fourth quarter and full year 2024 results as well as provide twenty twenty five full year guidance. Speaker 200:03:06I will close the call with discussion of our business outlook and our path forward into 2025 as we look ahead to continue the significant progress on our turnaround efforts. Then we'll open up the call for Q and A. I'll now begin on Slide five. I joined Emergent and this leadership team one year ago to turn around the business and focus on our company's mission to protect and save lives. For more than twenty five years, Emergent has responded to solutions to complex and urgent public health threats with preparedness efforts and active responses. Speaker 200:03:38However, the company needed to reduce its debt, improve profitability and pursue future growth at a rapidly evolving landscape. Turning to Slide six, our team immediately went to work developing and implementing a multiyear transformational plan to stabilize, turnaround and ultimately transform the emerging business. Executing on this plan required making difficult, but necessary decisions, including divesting sites and assets to improve our profitability. Through the great efforts of the entire team, we completed our first phase of plan, the stabilization phase, marked by a reduction in debt, a stronger balance sheet and a renewed focus on our mission. We are delighted to have completed this first phase ahead of schedule. Speaker 200:04:25In 2025, we'll be executing our turnaround phase and transforming the company to generate long term profitable growth. On Slide seven, we highlight our important accomplishments since we reported fiscal year twenty twenty three results last year. In 2024, we dramatically improved our financial position. This we believe gives us operating flexibility and the ability to focus on driving growth. Among those key actions, we delivered on our plan to stabilize the company and secure commitments, including reducing net debt, refinancing and extending the debt maturity to 2029. Speaker 200:05:03We improved profitability and operating cash flow. We strategically divested assets and streamlined our site network, while meeting internal product delivery commitments for customers and significantly improving operating margins. We reduced operating expenditures by $130,000,000 while delivering on our core product commitments. We refocused our core business segments to medical countermeasures in NARCAN nasal spray. Of note, we have continued to combat the opioid epidemic with NARCAN nasal spray. Speaker 200:05:34And in 2024, we distributed 11,000,002 dose cartons or 22,000,000 doses across The U. S. And Canada. We continue to be the market leader in a growing Naloxone nasal spray market. We've been on the front line supporting public health preparedness with The U. Speaker 200:05:51S. And other allied government customers to address threats like anthrax, smallpox, mPox and botulism and secured five fifty million dollars in MCM contract awards. And lastly, we resolved legacy legal and quality issues and improved our quality and compliance systems companywide. I want to underscore that we treat critical stabilization priority while ensuring the highest standards of patient safety, quality and compliance. Progressing to Slide eight, our success in 2024 allows us to focus on the following five key critical areas and goals for our 2025 plan: strong profit follow through from 2024 with a focus on higher net income, increased gross margin percentage and an increased adjusted EBITDA margin percentage Operating cash flow growth versus 2024 and strong positive free cash flow. Speaker 200:06:46Rebuilding our product pipeline, our CMO and Head of R and D, Doctor. Simon Lowry will be driving these efforts. Further optimization of manufacturing operations in partnership, potentially taking additional steps to streamline our manufacturing footprint. And lastly, strategic capital deployment for opportunistic growth through business development. These will be the right size investments that we see clear value and potential to harness our expertise and capabilities similar to our Cloxado business development transaction. Speaker 200:07:19Before handing to Rich, for a more detailed financial review, I'd like to set the stage for our 2025 guidance. We view guidance as a commitment to our stakeholders. Heading into 2025, we believe there are dynamics and factors that lead us to take a more conservative approach to guidance. The onboarding of a new administration may cause shifts in the timing of product deliveries or may cause uncertainty due to staff transitions. Over the course of more than twenty five years serving and partnering with government customers, we are very familiar with the gap between ships. Speaker 200:07:51Our products are mission critical, a belief and an understanding we believe that has been shared by many administrations and today enjoy bipartisan support for the importance of biodefense and decreasing opioid overdose deaths. Notwithstanding our conservative full year guidance, we believe we will have a strong first quarter. As standard practice, we plan to update our guidance every quarter as we have in the past years. Following Rich's comments, I'll spend some time elaborating on these areas. I'll now hand the call over to Rich. Speaker 100:08:23Thank you, Joe. Good afternoon, everyone. We appreciate you joining the call. Over the course of 2024, we made significant progress stabilizing the financial foundation of the business and have moved into the turnaround phase of our multi year transformational plan. Our unique set of medical countermeasure and opioid overdose reversal products provides life saving capabilities to people around the world, drives sustainable revenue over time and garners bipartisan support. Speaker 100:08:51And we believe the actions we have taken over the past two years have brought us to an inflection point in profitability and cash flow that will enable us to identify and pursue value creating growth opportunities as we move forward from here. Joe will have more to say about our vision after I run through the numbers. Our fourth quarter results were broadly in line with the guidance we provided on our third quarter call. Our key financial metrics are summarized on Slide 10. Total revenues of $195,000,000 down versus the prior year as lower NARCAN sales and anthrax sales timing were partially offset by higher smallpox sales. Speaker 100:09:27Adjusted EBITDA of $21,000,000 an increase of $18,000,000 versus the prior year. Total segment adjusted gross margin of 40% improved 800 basis points year over year as a result of product mix, as well as an improved cost structure stemming from our previously announced restructuring efforts. And a total reduction of $49,000,000 or 41% in operating expenses across R and D and SG and A versus the prior year. Of note, these expense levels now represent a dollar run rate that incorporates the full impact of our cost savings efforts. Transitioning to Slide 11 and our strong full year results, total revenues were $1,040,000,000 roughly flat versus the prior year. Speaker 100:10:12Total adjusted EBITDA of $183,000,000 which is a $2.00 $5,000,000 positive swing versus the negative $22,000,000 in 2023. Total adjusted gross margin of $457,000,000 an annual improvement of $121,000,000 or 1,200 basis points as a percentage of revenue. Full year operating expense of $379,000,000 was down $101,000,000 or 21% year over year with reductions in both R and D and SG and A driven by the cost actions taken in the second half of twenty twenty four. Moving to Slide 12, our full year revenue highlights were total product sales of $9.00 $9,000,000 a slight decline versus the prior year as increased smallpox revenue from both the U. S. Speaker 100:11:00Government and international customers was offset by lower NARCAN sales and the timing of anthrax sales. Within NARCAN, we continue to remain competitive on price and focused on our competitive advantages, including our brand recognition, market leading distribution capabilities and customer service. Full year volume was strong with 2024 levels consistent with 2023. Prices lower compared to 2023, but has stabilized in the back half of 2024. Total bioservices revenue of $105,000,000 represents an improvement year over year of $26,000,000 driven by the $50,000,000 1 time settlement agreement with Janssen. Speaker 100:11:42And finally, contracting grant revenue was $30,000,000 for 2024, primarily from the continued U. S. Government funding of the Yubonga program for treatment of Ebola. On Slide 13, we recap the material achievements that we accomplished ahead of expectations in 2024. We completed $117,000,000 of asset sales and received a $50,000,000 payment from Janssen Pharmaceuticals as a result of the confidential settlement agreement. Speaker 100:12:08We improved the overall cost structure with actions producing $130,000,000 of annualized savings in 2024. This brings the total operating expense savings to a $250,000,000 over the last two years, while maintaining capabilities across our core product portfolio. We also received $30,000,000 in development milestone payments from Bavarian Nordic. These key liquidity enhancements supported the refinancing of our prior secured credit facility as we entered into a new $250,000,000 term loan from Oak Hill Advisors, extending the maturity of our debt to August 2029. And we closed a $100,000,000 asset backed revolving credit facility led by Wells Fargo, also maturing in 2029. Speaker 100:12:53On Slide 14, we highlight the significant improvements to our financial metrics. At the end of twenty twenty four, we had total liquidity of $200,000,000 comprised of $100,000,000 of cash and $100,000,000 of undrawn revolver capacity. This outcome was aided by generating $59,000,000 of operating cash flow, an improvement of $265,000,000 year over year. As a result of refinancing our debt and the improved cash position, net debt at year end was $6.00 $1,000,000 a $156,000,000 or twenty one percent reduction since the beginning of 2024. This outcome coupled with the strong performance in the business materially lowered our net leverage to 3.3 times adjusted EBITDA. Speaker 100:13:36The credit rating agencies have also recognized the improved financial position of the company. Moody's and S and P both upgraded our corporate family credit rating to B3 and B- respectively with stable outlooks. I will also note that the prior going concern qualification has been removed from the audit opinion and financial disclosures that will be in our 10 K filing. Transitioning to Slide 15, it's important to note it's important to point out that total 2024 revenue of $1,040,000,000 includes approximately $115,000,000 that is no longer in the base as we begin 2025. First, the Janssen settlement agreement resulted in recognition of 50,000,000 of revenue in our bioservices business. Speaker 100:14:21And RSDL and Camden combined generated approximately $65,000,000 of revenue prior to their divestiture in the third quarter of twenty twenty four. Accordingly, as a starting point for 2025, the normalized 2024 revenue was roughly $930,000,000 With that backdrop, please turn to Slide 16 for full year 2025 guidance. Our total revenue guidance for 2025 is $750,000,000 to $850,000,000 As a reminder, Joe noted that we are being conservative due to the transitions anticipated in the new administration. We are forecasting 2025 adjusted EBITDA of $150,000,000 to $200,000,000 The midpoint is approximately consistent with 2024 full year results even in light of the lower revenue guidance. This highlights our significant efforts to improve the go forward cost structure and profitability of the business. Speaker 100:15:13We believe that this year may represent a trough in adjusted EBITDA going forward as we expect to grow our profitability from here. We're also anticipating a return to positive bottom line earnings. We forecast a range of net income from $16,000,000 to $66,000,000 and a range of adjusted net income from $20,000,000 to $70,000,000 For the full year of 2025, we're forecasting total segment adjusted gross margin of 48% to 51%, roughly a 500 basis point expansion at the midpoint versus 2024 results aided by our leaner and more focused manufacturing footprint. Moving to segment level revenue guidance, we're forecasting MCM product sales of $435,000,000 to $485,000,000 across U. S. Speaker 100:15:59Government and international orders. And we estimate a range of $265,000,000 to $315,000,000 in our commercial products, which includes both NARCAN and Cloxado. As part of this guidance, we expect NARCAN to continue to maintain a leading market share of the growing total addressable naloxone nasal spray market. And for the first quarter of twenty twenty five, we're forecasting a total revenue range of $200,000,000 to $240,000,000 which is a strong and healthy start to the year. In closing on Slide 17, we've entered the turnaround phase of our multi year plan ahead of schedule. Speaker 100:16:35We are anticipating strong profit follow through from 2024 even with lower top line revenue, which we are focused on improving from here. Our guidance therefore implies a very strong margin improvement story, which in combination with our expectations for continued positive operating cash flow and anticipated Bavarian Nordic milestone payments in 2025 positions us to capitalize on growth opportunities for the business as we move forward. For more on that, I'll now turn the call back over to Joe. Speaker 200:17:05Thank you, Rich. Turning to Slide 19, I'd like to provide context around the financials and our business outlook for 2025. Our mission to protect and save lives from opioid overdose is evident in the work we do to increase access, awareness and the availability over the counter NARCAN. NARCAN remains the market leader amongst intranasal naloxone products with an approximately 75% share of the market. We believe our continuous leadership and work to expand OTC access to NARCAN is a key contributor to the declining national rate of opioid overdose death recently reported by the CDC. Speaker 200:17:42But while this preliminary data points the first meaningful decline in opioid overdose deaths in years, we are still seeing the devastating effects of opioid overdose. Tragically, rates of opioid overdose remain high in Canada, especially in British Columbia, Ontario, Alberta Speaker 300:18:00and the indigenous communities. Speaker 200:18:02In The U. S, the public interest channel is backed by over $50,000,000,000 in opioid settlement funds from large pharma companies that are expected to flow through over the next ten to fifteen years and another $3,500,000,000 in federal grants supporting Nalaxone access in 2025. This funding remains critical as there are still an unacceptable number of opioid overdoses and deaths caused by fentanyl. I'd like to review the critical element that underpin our NARCAN franchise as we work to continue reducing opioid overdose deaths in 2025. The NARCAN nasal spray value drivers continue to support a differentiated and competitive price point for our customers. Speaker 200:18:46We expect to maintain market share leadership and anticipate the total Natlaxone market unit volume will grow by mid to high single digit rates. We are expanding reach into businesses and one important aspect of this work is our commercial engagement with the National Safety Council. We are starting to make headway to several major companies that are prioritizing first aid safety kits with OTC NARCAN. Our hope is that someday every first aid kit in The U. S. Speaker 200:19:18And Canada will include a box of NARCAN nasal spray. We've built a national logistics network, NARCAN Direct, which serves 18,000 different endpoints for public interest customers. This program allows them to get the product volumes that they need when they need it. We believe today that no other company has the capability and no one can match our NARCAN nasal spray production capacity. As we announced in January, we secured commercial rights for product sales and marketing in U. Speaker 200:19:50S. And Canada to cloxidil nasal spray from Hikma. This additional solution helps expand Emergent's ability to distribute multiple life saving opioid overdose emergency treatments to patients, customers and communities in need. In summary, we believe NARCAN is the standard of care and plays an important role in reducing the number of overdoses that result in death. And given Emergent's proven track record of supplying NARCAN nasal spray to states, first responders, law enforcement, community groups and other organizations, adding Cloxado nasal spray provides customers with the flexibility to tailor their treatment for specific patients. Speaker 200:20:33Moving to Slide 20, our MCM business, it's worth noting. We're continuing to provide essential biodefense services for an increasingly dangerous world that we live in, where bioterror threats are constant and at the same time ever changing. The four key priority threats for the administration for strategic preparedness and response are anthrax, smallpox, Ebola and botulism. And there are aligned the key focal points of our MCM portfolio. We believe biodefense portfolio is well positioned with visibility into future recurrence based on our long term contracts. Speaker 200:21:13As a reminder, we received $550,000,000 in biodefense contract modifications in 2024. It is also important to note that Department of Defense has a mandatory funding obligation for BioThrax, which is a pre and post exposure anthrax vaccine from military personnel. We see opportunities to continue playing active part in addressing the ongoing m pox outbreak with AGM2000. We're also enthusiastic about the potential of our other MCN products, including Tempexa and Evanga and their ability to contribute to future growth. We have a U. Speaker 200:21:51S. Government funding committed through 2027 for Temvexa, which further demonstrates our MCM assets are important for biodefense. Moving to Slide 21 with respect to important catalyst to enable growth in 2025, we are looking forward to the ACAM2000 emergency use lifting with the World Health Organization as the MPOS public health upgrade continues to evolve. We remain focused on revenue diversification within our existing businesses and improving our core capabilities to drive revenue growth. This includes opportunities to drive growth such as the anticipated incremental revenue to be generated by Cloxado Nasal Spray. Speaker 200:22:33At the same time, we will be looking internationally for growth opportunities across our product portfolio. I'd like to note that we're also anticipating $50,000,000 of Bavarian Nordic chikungunya vaccine approval milestone payments starting in the next thirty days. As we execute on our 2025 turnaround initiative, we will strive for the highest standard for quality, ethics and compliance. In closing, for all the reasons we have discussed, we believe Emergent is poised for a significant turnaround opportunity that we believe will lead to profitable and sustained growth. And with that, I look forward to taking your questions. Speaker 200:23:11Operator, if you could open the lines for your questions, please. Operator00:23:28Our first question coming from the line of Jessica Fye with JPMorgan. Your line is now open. Speaker 400:23:36Hey, this is Nick on for Jess. Thanks for taking your questions. First, on your NARCAN guidance, can you just provide a bit more specifics on the underlying assumptions around maybe volume and price? I think you say that you expect growth for the overall market and while you expect to maintain leading share in that market. Can you just comment on how that's broken down in the pit market versus other channels? Speaker 400:23:57Just how much share you expect in 2025 relative to 2024? And any guidance on maybe additional pricing pressure in that market? Speaker 200:24:08Sure. Try to take the first part of it and go and I'll just fill in some other parts, but go ahead. Okay. Speaker 100:24:13All right. Thanks, Nick. Appreciate the question. So we've talked about on our last call how the pricing in the first half versus the second half was differential, but that we had seen stabilization in the pricing in the second half. We've broadly seen that continue as we've come into this year. Speaker 100:24:33Having said that, we do expect there to be a follow through impact of that reduction in pricing that we saw in the second half to impact the full year results. I would say that is the biggest driver of the guidance as we go forward into 2025. We have put a fairly wide range to reflect a range of outcomes. We think it's a fairly conservative range and we'll certainly update that as we go through the year. We do continue to anticipate that we'll maintain a very strong and certainly majority market share of the pit market as we go forward. Speaker 100:25:10And I think that's those are the comments that we'll make at Speaker 200:25:14this point. Sure. Maybe just yes, one of the points public interest, I think, is about 75% of our total business, I think, was one of the questions we had inserted in there as well, but I think Richard answered everything else. Speaker 400:25:27Great. And then maybe on yes, just one more. You guys are guiding to adjusted EBITDA in 2025, that's roughly flat year over year at the midpoint. I know you kind of commented on 2025 guidance, you're kind of representing a trough, but how are you thinking about that evolving maybe in 2026 plus on a magnitude basis? And how sensitive is that to the NARCAN dynamics that you're seeing? Speaker 200:25:55Yes. Well, I think one of the things we're doing now as we think about the businesses, we have a diversified business where you've got a number of different assets, obviously with medical countermeasures in NARCAN and now Clapsodo. And as I think Rich mentioned, I mentioned that we continue to look to do some additional business development opportunities in 2025 and beyond. So I think it's really those all of those that will contribute to the overall growth, there are opportunities for growth in our adjusted EBITDA. Obviously, we're not going to say anything specifically about the 2026 yet, but I think it's going to be diversification of our portfolio, the additional organic opportunities we have with what we're doing with Tempexa, what we are doing with the EBONGA for Ebola, what we're doing for the MPOX opportunity. Speaker 200:26:43We did not build MPOX into our 2025 guidance at this time, but we obviously are looking to continue to extend that. That would be an upside for us if we're we're fortunate enough to get that business. So those are all the things that we think will help drive the internal opportunities for 2026. Obviously, on the external business development side, we've got certainly ClogSado and then what other types of business development deals we can do for the future with other companies that are either working in the area of the biodefense medical countermeasures or companies that are working with products for first responders. Those will be the two main avenues which we will pursue for additional business development. Speaker 200:27:26But that would be the probably the main things I'd add to the 2026 question. Speaker 400:27:32Great. Thank you. Speaker 200:27:33Operator, let's take our next question please. Operator00:27:37Thank you. Our next question coming from the line of Brandon Folkes with Rodman and Renshaw. Your line is now open. Speaker 300:27:44Hi. Thanks for taking my questions and I appreciate all the color. Sorry to stick on the 2026 theme here, but I think it's just important. Can you just talk about sort of the SG and A OpEx, sorry not SG and A, but the broader OpEx footprint in your guidance for 2025? How do you think about that sort of beyond 2025? Speaker 100:28:09Yes. I think as I commented on the call, I think as we came out of the fourth quarter, we've got the full benefit of the actions that we've taken in the run rate for the fourth quarter. I think we'll stay focused on continuing to scale the SG and A footprint along with the business as we grow revenue. So I think that there will be opportunities for us to look for additional efficiency improvements on SG and A. Speaker 200:28:34And I think you're seeing that and what Rich was saying, but as you look at what's happening with everything from the gross adjusted gross margin, just overall margins that we're expecting when you do like an operating reduction. So I think all those are packaged together as how we're looking at the expenses we've been taking out of the business in 2023 and 2024 and now we're seeing the full year benefit of it in 2025. Speaker 300:28:59Great. Thanks. And maybe just coming back to KLAXADA, if I said that correctly. How are you going to position that relative to NACA? I know you mentioned sort of now that you own it, some there are some users of it. Speaker 300:29:14I can see it obviously plugging into your distribution system. But do you expect to grow Clixado by sort of positioning it in any way or really being a distribution driven growth story? Speaker 200:29:29First and foremost, when we acquired Cloxado, we made the comment that we think Cloxado is a great opportunity to leverage the platform we have today, for example, with NARCAN Direct programs. Will make it easier for first responders to get access to the product by making it work through our NARCAN Direct distribution capability. So first and foremost, we think it's going to be easier to do business as we put together CLXADA with NARCAN N into our distribution capabilities. Number two, I think as you know and people you read in the news, there are increasing number of fentanyl overdose or fentanyl is causing an increased percentage of the overdoses out there. We think Cloxado may be appropriate for some of those increased fentanyl dosages that are out there in the marketplace. Speaker 200:30:20We want to make sure that if needed, we have Cloxado. If needed, we have a standard of care with NARCAN. Either way, the first responder goes, we think we have the capability to make it easier for them to get what they need for their for the patients and the individuals throughout their treating. So look to us to really just leverage our current distribution and capability with our sales force and put our one more product in their hands to help all of our customers with it. So that's the primary way we'll do it. Speaker 200:30:52Average individual first responders are always going to have to make the judgment as to whether or not they need a four milligram or an eight milligram. We believe that four milligram is the standard of care, but there is an increasing need for eight milligrams and we're glad to have that capability now with the Cloxado transaction. Speaker 300:31:11Great. Thank you very much. Speaker 100:31:13Thank you. Speaker 200:31:14Operator, next question please. Operator00:31:17Our next question coming from the line of Raghuram Saldan Raju with H. C. Wainwright. Your line is now open. Speaker 500:31:27Hi. This is Eduardo on for Ram from H. C. Wainwright. I guess I was I guess we're talking about Quixado. Speaker 500:31:34I wanted to ask, just confirming that it's already available within the NARCAN Direct system and if not, when do you expect that to happen? Speaker 200:31:43Yes. So we announced the transaction in January and now we're working through all the logistics there currently. Obviously, Hikma had some product in the system already. So we're working through all the logistics now and we expect to have it in the next thirty to sixty days is when we'll have it going through our ordering capabilities. But you obviously want to make it easy for the first responders for them to order it to work through our system. Speaker 200:32:07So we're working through all those details to ensure that it's easier for the first responders to get the product and make it a value add for them, not make it a difficult process. So look to us that have more to say about that in the next thirty to sixty days. Speaker 500:32:23Got it. That's really helpful. And just pivoting towards MPoX, just curious if the MOSA trial is still on track for its first interim analysis during the end of this first quarter? Speaker 200:32:39So what we're doing with mPox is we're working with World Health Organization specifically to get the emergency use label. We expect to hear more from them sometime in the near future. Obviously, as we go through changes in administration, changes in policy, we're working through all the questions there, but we'll just have more to say about that specifically as we get feedback from the World Health Organization. Specific to additional clinical trial work, we're doing that clinical trial work, especially with IMVEXXA and with looking to get additional data on our ACAM product. That's not something specifically that we're going to talk too much about right now, but we do have additional clinical trials under work in the small underway in the smallpox area. Speaker 500:33:33Understood. Thanks. And I guess one last one regarding other MCM. Do you have any or do you expect any further near term contract adjustments or option exercises under procurement orders for the biodefense products? And if so, which ones? Speaker 100:33:51Yes. This is Rich, Eduardo. I think what you should expect is that kind of the pattern that was followed in 2024 is a good marker for what is likely to happen in 2025. The timing of specific option exercises could shift from one quarter to another, but broadly speaking, we expect that the U. S. Speaker 100:34:13Government is going to continue to execute against those contracts and issue us procurement orders as we go through the year. Speaker 200:34:20And the only thing I'd add to what Rich said is once again, he said in his own comments during the call, but I think we expect a strong first quarter as a result of the activities we had in 2024. Just really the momentum we had exiting 2024 is going to allow us to have a very strong first quarter, which we obviously think is a great way to start the New Year. Speaker 500:34:42Great. Thanks so much for the clarity. Operator00:34:47Thank you. And I'm showing no further questions in the queue. I will now turn the call back over to Mr. Joe Papa for any closing remarks. Speaker 200:34:55Thank you, operator. Thank you, everyone, for joining us, ladies and gentlemen. We appreciate everyone's attention to our earnings call today. Thank you for your participation. Please note an archived version of today's webcast as well as PDF version of our slides used today will be available on our website accessible through in the Investors landing page on the company website. Speaker 200:35:16Thank you again for joining us. We look forward to speaking with all of you in the near future. Have a great day. Operator00:35:22This concludes today's conference call. Thank you for your participation and you may now disconnect.Read moreRemove AdsPowered by