Emergent BioSolutions - Earnings Call - Q4 2024

Executive Summary

• Q4 revenue fell 30% to $194.7M on sharp declines in NARCAN (-41%) and Anthrax MCM (-71%), partially offset by a 565% surge in Smallpox MCM; GAAP diluted EPS was $(0.58) and Adjusted EBITDA was $21.0M, with total segment adjusted gross margin improving to 40%.
• Management initiated conservative FY2025 guidance: revenue $750–$850M, Adjusted EBITDA $150–$200M, net income $16–$66M, and total segment adjusted gross margin 48–51%; Q1 2025 revenue guided to $200–$240M, with a strong start expected and a margin expansion focus despite lower top line.
• Balance sheet and liquidity improved: YE 2024 cash ~$100M, net debt ~$600.5M (3.3x TTM Adjusted EBITDA), and total liquidity of ~$200M (cash + undrawn revolver); going concern qualification removed, and ratings upgraded (Moody’s B3, S&P B-).
• Strategic catalysts: exclusive U.S./Canada commercial rights to 8mg KLOXXADO (naloxone) to complement OTC NARCAN 4mg; potential WHO Emergency Use Listing for ACAM2000 for mpox; visibility into future U.S./international MCM procurements.

What Went Well and What Went Wrong

What Went Well

• Smallpox MCM momentum: Q4 Smallpox MCM sales jumped 565% YoY to $76.5M, driven by higher ACAM2000 non-U.S. sales and USG timing on VIGIV CNJ-016.
• Cost discipline and margins: Q4 total segment adjusted gross margin rose 800 bps YoY to 40%; R&D and SG&A were down $49M (41%) YoY, reflecting restructuring and cost actions (CFO).
• Balance sheet repair: YE 2024 net leverage fell to 3.3x Adjusted EBITDA with ~$200M liquidity; going concern qualification removed; both Moody’s and S&P raised ratings (CFO).

Management quotes:

• “We completed our first phase [stabilization] ahead of schedule… In 2025, we'll be executing our turnaround phase” (CEO).
• “Total segment adjusted gross margin of 40% improved 800 basis points year over year… expense levels now represent a dollar run rate that incorporates the full impact of our cost savings efforts” (CFO).
• “We believe that this year may represent a trough in adjusted EBITDA going forward as we expect to grow our profitability from here” (CFO).

What Went Wrong

• NARCAN revenue pressure: Q4 NARCAN fell 41% YoY to $65.1M on lower OTC sales and Canada retail; pricing declined in 1H’24 and stabilized in 2H, but lower pricing will still weigh on 2025 (CFO).
• Anthrax MCM timing: Q4 Anthrax MCM revenue dropped 71% YoY to $32.5M due to timing of USG purchases/options (lumpy procurement).
• Bioservices reset: Q4 Bioservices revenue fell 64% YoY (Camden sale; Bayview compares to prior-year resolution); full-year Services gross margin was deeply negative due to Janssen settlement accounting (net $110.2M) and lower Canton production.

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to Emergent BioSolutions' fourth quarter 2024 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automatic message voice when your hand is raised. Please note that today's conference is being recorded. I would now like to turn the call over to Frank Vargo, VP and Assistant Treasurer. Please go ahead.

Frank Vargo (VP and Assistant Treasurer)

Good 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, during 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, Emergent does 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 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. Please 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 of 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&A.

Finally, for the benefit of those who may be listening to the replay of this webcast, this call was held and recorded on March 3rd, 2025. Since then, Emergent may have made announcements related to topics discussed during today's call. With that, I would now like to turn the call over to Joe Papa for opening remarks. Joe?

Joe Papa (CEO)

Thank you, Frank. Hello, everyone, and thank you for joining us to discuss our fourth quarter and full year 2024 earnings. I'm joined today by Rich Lindahl, 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 2025 full-year guidance. I will close the call with a discussion of our business outlook and our path forward into 2025 as we look ahead to continue the significant progress on our turnaround efforts. We will open up the call for Q&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 25 years, Emergent has responded with solutions to complex and urgent public health threats with preparedness efforts and active responses. However, the company needed to reduce its debt, improve profitability, and pursue future growth in a rapidly evolving landscape. Turning to slide six, our team immediately went to work developing and implementing a multi-year transformational plan to stabilize, turn around, and ultimately transform the Emergent 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 the 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. In 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 2023 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. We 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 improved operating margins. We reduced operating expenditures by $130 million while delivering on our core product commitments.

We refocused our core business segment to medical countermeasures and Narcan nasal spray. Of note, we have continued to combat the opioid epidemic with Narcan nasal spray, and in 2024, we distributed 11 million two-dose cartons or 22 million 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.S. and other allied government customers to address threats like anthrax, smallpox, mpox, and botulism , and secured $550 million in MCM contract awards. Lastly, we resolved legacy legal and quality issues and improved our quality and compliance systems company-wide. 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 a strong positive free cash flow. Rebuilding our product pipeline, our CMO and Head of R&D, Dr. Simon Lowry, will be driving these efforts. Further optimization of manufacturing operations and partnerships, potentially taking additional steps to streamline our manufacturing footprint. Lastly, strategic capital deployments for opportunistic growth through business development. These will be the right-sized investments that we see clear value and potential to harness our expertise and capabilities similar to our Kloxxado business development transaction.

Before handing it 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 delivery or may cause uncertainty due to staff transitions. Over the course of more than 25 years serving and partnering with government customers, we are very familiar with adapting to these shifts. Our products are mission-critical. A belief and an understanding we believe that have 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.

Rich Lindahl (EVP and CFO)

Thank 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. 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 million, down versus the prior year as lower Narcan sales and anthrax sales timing were partially offset by higher smallpox sales. Adjusted EBITDA of $21 million, an increase of $18 million 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. A total reduction of $49 million, or 41%, in operating expenses across R&D and SG&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 in our strong full-year results, total revenues were $1.04 billion, roughly flat versus the prior year.

Total adjusted EBITDA of $183 million, which is a $205 million positive swing versus the negative $22 million in 2023. Total adjusted gross margin of $457 million, an annual improvement of $121 million, or 1,200 basis points as a percentage of revenue. Full-year operating expense of $379 million was down $101 million, or 21% year over year, with reductions in both R&D and SG&A driven by the cost actions taken in the second half of 2024. Moving to slide 12, our full-year revenue highlights were total product sales of $909 million, a slight decline versus the prior year as increased smallpox revenue from both the U.S. government 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. Price is lower compared to 2023 but has stabilized in the back half of 2024. Total bioservices revenue of $105 million represents an improvement year over year of $26 million, driven by the $50 million one-time settlement agreement with Janssen. Finally, contract and grant revenue was $30 million for 2024, primarily from the continued U.S. government funding of the Ebanga program for treatment of Ebola. On slide 13, we recap the material achievements that we accomplished ahead of expectations in 2024. We completed $117 million of asset sales and received a $50 million payment from Janssen Pharmaceuticals as a result of the confidential settlement agreement. We improved the overall cost structure with actions producing $130 million of annualized savings in 2024.

This brings the total operating expense savings to $250 million over the last two years, while maintaining capabilities across our core product portfolio. We also received $30 million 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 million term loan from Oak Hill Advisors, extending the maturity of our debt to August 2029. We closed a $100 million asset-backed revolving credit facility led by Wells Fargo, also maturing in 2029. On slide 14, we highlight the significant improvements to our financial metrics. At the end of 2024, we had total liquidity of $200 million, comprised of $100 million of cash and $100 million of undrawn revolver capacity. This outcome was aided by generating $59 million of operating cash flow, an improvement of $265 million year over year.

As a result of refinancing our debt and the improved cash position, net debt at year-end was $601 million, a $156 million, or 21% reduction since the beginning of 2024. This outcome, coupled with the strong performance in the business, materially lowered our net leverage to 3.3x adjusted EBITDA. The credit rating agencies have also recognized the improved financial position of the company. Moody's and S&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 $1.04 billion includes approximately $115 million that is no longer in the base as we begin 2025.

First, the Janssen Settlement Agreement resulted in recognition of $50 million of revenue in our bioservices business. RSDL and Camden and Canton combined generated approximately $65 million of revenue prior to their divestiture in the third quarter of 2024. Accordingly, as a starting point for 2025, the normalized 2024 revenue was roughly $930 million. With that backdrop, please turn to slide 16 for full-year 2025 guidance. Our total revenue guidance for 2025 is $750 million-$850 million. 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 million-$200 million. 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.

We 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 million-$66 million and a range of adjusted net income from $20 million-$70 million. For the full year of 2025, we're forecasting total segment adjusted gross margin of 48%-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 million-$485 million across U.S. government and international orders. We estimate a range of $265 million-$315 million in our commercial products, which includes both Narcan and Kloxxado nasal spray.

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. For the first quarter of 2025, we're forecasting a total revenue range of $200 million-$240 million, 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. We 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.

Joe Papa (CEO)

Thank 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 availability of 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 deaths recently reported by the CDC. While this preliminary data points to 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, and the Indigenous communities.

In the U.S., the public interest channel is backed by over $50 billion in opioid settlement funds from large pharma companies that are expected to flow through over the next 10-15 years, and another $3.5 billion in federal grants supporting naloxone 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 elements 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. We expect to maintain market share leadership and anticipate the total naloxone 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 in 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. and 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 the U.S. and Canada to Kloxxado nasal spray from Hikma.

This additional solution helped expand emergency ability to distribute multiple lifesaving 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. Given Emergent's proven track record of supplying Narcan nasal spray to states, first responders, law enforcement, community groups, and other organizations, adding Kloxxado nasal spray provides customers with the flexibility to tailor their treatment for specific patients. Moving 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 they are aligned to the key focal points of our MCM portfolio. We believe the biodefense portfolio is well-positioned with visibility into future procurements based on our long-term contracts. As a reminder, we received $550 million in biodefense contract modifications in 2024. It is also important to note that the Department of Defense has a mandatory funding allocation for BioThrax, which is a pre- and post-exposure anthrax vaccine for military personnel. We see opportunities to continue playing an active part in addressing the ongoing mpox outbreak with ACAM2000. We're also enthusiastic about the potential of our other MCM products, including Tembexa and Ebanga, and their ability to contribute to future growth. We have a U.S.

Government funding committee through 2027 for Tembexa, which further demonstrates our MCM assets are important for biodefense. Moving to slide 21, with respect to important catalysts to enable growth in 2025, we are looking forward to the ACAM2000 emergency use listing with the World Health Organization as the mpox public health outbreak 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 Kloxxado nasal spray. At 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 million of Bavarian Nordic chikungunya vaccine approval milestone payments starting in the next 30 days.

As we execute on our 2025 turnaround initiative, we will strive for the highest standards of 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. I look forward to taking your questions. Operator, if you could open up and answer questions, please.

Operator (participant)

Certainly. Ladies and gentlemen, as reminded to ask the question, you will need to press star 11 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster. Our first question coming from the line of Jessica Fye with JPMorgan. Your line is now open.

Nick Richitt (Managing Director)

Hey, this is Nick Richitt. 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 stated that you expect growth for the overall naloxone market, and while you expect to maintain a leading share in that market, can you just comment on how that's broken down in the PIT market versus other channels, just how much share you expect in 2025 relative to 2024, and any guidance on maybe potential additional pricing pressure in that market?

Joe Papa (CEO)

Sure. We're trying to take the first part of it and go without filling some other parts, but go ahead.

Rich Lindahl (EVP and CFO)

Okay. All right. Thanks, Nick. Appreciate the question. We 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 have broadly seen that continue as we have come into this year. Having 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 is a fairly conservative range, and we will 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. I think those are the comments that we'll make at this point.

Joe Papa (CEO)

Sure. Maybe just, yeah, I think you asked one other point. Public interest, I think, is about 75% of our total business. I think it was one of the questions you had inserted in there as well, but I think Rich answered everything else.

Nick Richitt (Managing Director)

Great. Maybe on—oh, sorry, just one more. You guys are guiding to adjusted EBITDA in 2025. It is roughly flat year over year at the midpoint. I know you kind of commented on 2025 guidance here kind of representing a trough, but how are you thinking about it evolving maybe in 2026 plus on a magnitude basis, and how sensitive is that to the Narcan dynamics that you are seeing?

Joe Papa (CEO)

Yeah. I think one of the great things we're doing now, if 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 Kloxxado. As I think Rich mentioned, I mentioned that we continue to look to do some additional business development opportunities in 2025 and beyond. I think it's really all those that will contribute to the overall growth, their opportunities for growth in our adjusted EBITDA. Obviously, we're not going to say anything specifically about 2026 yet, but I think it's going to be the diversification of our portfolio, the additional organic opportunities we have with what we're doing with Tembexa, what we are doing with the Ebanga for Ebola, what we're doing for the Mpox opportunity.

We 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 fortunate enough to get that business. Those are all the things that we think will help drive the internal opportunities for 2026. Obviously, on the external or business development side, we've got certainly Kloxxado, 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. That was the reason, probably the main things I'd add to the 2026 question.

Nick Richitt (Managing Director)

Great. Thank you.

Joe Papa (CEO)

Hey, Everett, you want to take our next question, please?

Operator (participant)

Thank you. Our next question coming from the line of Brandon Folkes with H.C. Wainwright. Your line is now open.

Brandon Folkes (Managing Director and Senior Analyst)

Hi. 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&A OpEx—sorry, not SG&A, but the broader OpEx footprint in your guidance for 2025? How do you think about that sort of beyond 2025?

Rich Lindahl (EVP and CFO)

Yeah. 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&A footprint along with the business as we grow revenue. I think that there will be opportunities for us to look for additional efficiency improvements on SG&A.

Joe Papa (CEO)

I think you're seeing that in what Rich was saying, but you look at what's happening with everything from an adjusted gross margin, just overall margins that we're expecting when you do an operating reduction. 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.

Brandon Folkes (Managing Director and Senior Analyst)

Great. Thanks. Maybe just coming back to Kloxxado, I hope I said that correctly. How are you going to position that relative to Narcan? I know you mentioned sort of now that you own it, some are some users of it. I can see it obviously plugging into your distribution system, but do you expect to grow Kloxxado by sort of positioning it in any way or really being a distribution-driven growth story?

Joe Papa (CEO)

First and foremost, when we acquired Kloxxado, we made the comment that we think Kloxxado is a great opportunity to leverage the platform we have today, for example, with Narcan Direct programs. We'll make it easier for first responders to get access to the product by making it work through our Narcan Direct distribution capability. First and foremost, we think it's going to be easier to do business as we put together Kloxxado with Narcan into our distribution capabilities. Number two, I think as you know and people you read in the news, there are increasing numbers of fentanyl overdose or fentanyl is causing an increased percentage of the overdoses out there. We think Kloxxado may be appropriate for some of those increased fentanyl dosages that are out there in the marketplace. We want to make sure that if needed, we have Kloxxado.

If needed, we have the 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 the patients and the individuals throughout their treating. Look to us to really just leverage our current distribution and capability with our salesforce and put one more product in their hands to help all of our customers with it. That is the primary way we will do it. Average individual first responder is always going to have to make the judgment as to whether or not they need a 4 mg or an 8 mg. We believe that 4 mg is the standard of care, but there is an increasing need for 8 mg, and we are glad to have that capability now with the Kloxxado transaction.

Brandon Folkes (Managing Director and Senior Analyst)

Great. Thank you very much.

Joe Papa (CEO)

Thank you. Operator, next question, please.

Operator (participant)

Our next question coming from the line of Ram Selvaraju with H.C. Wainwright. Your line is now open.

Eduardo Rafael Martinez-Montes (Biotechnology Equity Research Analyst)

Hi. This is Eduardo on for Ram from H.C. Wainwright. I guess I was—I guess we're talking about Kloxxado. I 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?

Joe Papa (CEO)

Yeah. We announced the transaction in January, and now we're working through all the logistics there. Currently, obviously, Hikma has the product in the system already. We're working through all the logistics now, and we expect to have it in the next 30-60 days is when we'll have it going through our ordering capabilities. We obviously want to make it easy for the first responders for them to order it to work through our system. 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. Look to us to have more to say about that in the next 30-60 days.

Eduardo Rafael Martinez-Montes (Biotechnology Equity Research Analyst)

Got it. That's really helpful. I guess pivoting towards Mpox, curious if the MOSA trial is still on track for its first interim analysis during the end of this first quarter?

Joe Papa (CEO)

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 look to us to 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 Tembexa 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 underway in the smallpox area.

Eduardo Rafael Martinez-Montes (Biotechnology Equity Research Analyst)

Understood. Thanks. I guess one last one regarding other MCM. Do you have any or do you expect any further near-term contract adjustments, option exercises, or new procurement orders for the biodefense products? If so, which ones?

Rich Lindahl (EVP and CFO)

Yeah. This is Rich Lindahl. 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. government is going to continue to execute against those contracts and issue us procurement orders as we go through the year.

Joe Papa (CEO)

The only thing I'd add to what Rich said is, once again, he said it 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.

Eduardo Rafael Martinez-Montes (Biotechnology Equity Research Analyst)

Great. Thanks so much for the clarity.

Operator (participant)

Thank you. Now 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.

Joe Papa (CEO)

Thank 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 the PDF version of our slides used today, will be available on our website and accessible in the investors' landing page on the company website. Thank you again for joining us. We look forward to speaking with all of you in the near future. Have a great day.

Operator (participant)

This concludes today's conference call. Thank you for your participation, and you may now disconnect.