Emergent BioSolutions Inc. Price & Performance (EBS)

Good afternoon, everyone. 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 Bio In addition to today's press release, there's 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. Forward looking statements are based on their current intentions beliefs and expectations regarding future events Any forward looking statements 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 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 multiyear 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 and A. Finally, for the benefit of those who may be listening to the replay of this webcast, discussed during today's call. Would now like to turn the call over to Joe Papa for opening remarks. [indiscernible] Thank you, Frank. Hello, everyone, and thank you for joining us to discuss our fourth quarter and full year 2024 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, [indiscernible] will detail our fourth quarter and full year 2024 results as well as provide 2025 full year guidance. 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.

Then we'll open up the call for Q and A. I'll now begin on Slide five. I joined Emergent Emergent 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 with solutions to complex and urgent public health threats with preparedness efforts and active responses However, the company needed to reduce its 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 In 2025, we'd be executing our turnaround phase and transforming the company to generate long term profitable growth. On Slide seven, we highlight our important accomplishments as 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 [indiscernible] reducing net debt, refinancing and extending the debt maturity to 2029. We improved profitability and operating cash flow strategically divested assets and streamlined our site network while meeting internal product delivery commitments customers and significantly improvement operating Emergent. Reduced operating expenditures by $130,000,000 while delivering on our core product commitments.

We refocused our core business to medical countermeasures in NARCIA nasal spray, Of note, we have continued to combat the opioid epidemic with NARCIA and nasal spray In 2024, we distributed eleven million two dose cartons or 22,000,000 doses across The U. S. And Canada. We continue to be the market leader in a growing Naloxo 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, [indiscernible] [indiscernible] secured $550,000,000 in MCM contract awards. And lastly, we resolved legacy legal and quality issues and improved our quality and compliance [indiscernible] I want to underscore that we treat [indiscernible] stabilization priority while ensuring the highest standards [indiscernible] [indiscernible] [indiscernible] 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. [indiscernible] profit follow through from 'twenty four 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. Rebuilding our product pipeline, our CMO and Head of R and D, Doctor.

Simon Lowery, 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 [indiscernible] our expertise and capabilities similar to our Klax Auto business development transaction. For organic to Rich, I want for a more detailed financial review 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 in fact 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 [indiscernible] Our products are mission critical a belief and an understanding we believe that has been shared by many administrations 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 [indiscernible] first quarter.

As standard practice, we claim to update our guidance every quarter 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 Thank you, Joe.

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. Drive sustainable revenue over time, and garners bipartisan support. And 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. 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. [indiscernible] down versus the prior year as lower NARCAN sales and Amtrac sales timing were partially offset by higher smallpox sales.

Adjusted 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. Total 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 [indiscernible] 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.

We 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 of 2020 Total bioservices revenue of $105,000,000 represents an improvement year over year of $26,000,000 driven by the $50,000,000 one time settlement agreement, which [indiscernible] And finally, contract and grant revenue was $30,000,000 for 2024, primarily from the continued U. S. Government funding of the Ebonga program for treatment of Ebola. [indiscernible] Slide 13, we recap the material achievements that we accomplished to 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. [indiscernible] improved the overall cost structure with actions producing $130,000,000 of annualized savings in 2024. This brings the total operating expense savings to $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. On Slide 14, we highlight the significant improvements to our financial metric 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 21% 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 The 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 and B- respectively, with stable outlooks. I will also note that the prior going concern qualification has been removed from the opinion and financial disclosures that will be in our 10 ks filing. [indiscernible] 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 of $50,000,000 of revenue in our bioservice And RSBL 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 guide. This highlights our significant efforts to improve the go forward cost structure and profit We believe that this year may represent a trough in adjusted EBITDA going forward as we expect to grow our profitability from 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, 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. Government and international orders and we estimate a range of $2.65 $315,000,000 in our commercial products. Which includes both NARCAN and KlOXATA. As part of this guidance, we expect NARCAN to continue to maintain a leading market share of [indiscernible] 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 multiyear plan ahead of schedule. We are anticipating strong profit follow through from 2020 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.

Thank you, Rich. Turning to Slide 19, I'd like to 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, availability of over the counter NARCAN NARCAN remains the market leader amongst intranasal naloxone products within approximately 75% share of the market. We believe our continuous leadership in to the declining national rate of opioid overdose death recently reported by the CDC. But while this preliminary data points the first meaningful decline in overhead overdose deaths in years, we are still seeing the devastating effects of opioid overdose Tragically, opioid overdose remained high in Kansas especially in the British Columbia, Ontario, Alberta and the indigenous communities. In The U. S, the public interest channel is backed by over $50,000,000,000 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 grid supporting Nelaxone access in 2025 This funding means critical as there are still an unacceptable number of opioid overdoses. And deaths caused by fentanyl. I'd like to review the critical Emergent to underpin our NARCAN franchise as we work to continue reducing opioid overdose deaths. 2025, [indiscernible] 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 Natlaxo market unit volume will grow by mid to mid to high single digit [indiscernible] We are expanding reach into businesses and one important aspect of work is our commercial engagement to National Safety Council, are starting to make headway to several major companies that are prioritizing first aid safety kits with OTC Our hope 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 national logistics network NARCAN Direct, which serves 18,000 different endpoints for public interest [indiscernible] 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. S. And Canada to clock [indiscernible] [indiscernible] This additional solution helped expand Emergent's ability to distribute multiple life saving opioid overdose diversity treatments to patients, customers and communities in need. In summary, 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 [indiscernible] provides customers with the flexibility to tailor their treatment for specific patient Moving to Slide 20, our MCM business, it's worth noting We're continuing to provide essential biodefense services for increasingly dangerous world that we live in, where bioterror threats are constant and at the same time ever changing. The four key priorities threats of the administration for strategic preparedness in response are anthrax, [indiscernible] Ebola, and there are aligned the key focal points of our MCM We believe BioDefense portfolio is well positioned with visibility into future recurrences based on our long term contracts. As 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 for BioThrax, which is a pre and post exposure anthrax vaccine from We see opportunities for to continue playing an active part in addressing the ongoing m pox outbreak with AGM-two thousand We're also enthusiastic about the potential of our other [indiscernible] and Ibanga and their ability to contribute to future growth. Have U. S. Government funding committed through 2027 for Kinbexa, which further demonstrates our MCM assets are important for BioDefense. Moving to Slide '21, with we are looking forward to the ACAM2000 Emergent use lifting with the World Health Organization MPOX public health upgrade continues to evolve. We remain focused on revenue diversification [indiscernible] improving our core capabilities to drive revenue growth. This includes opportunities to drive growth such as the anticipated incremental revenue to be generated by [indiscernible] At the same time, we will be looking internationally for growth opportunities across our product force I'd like to note that we're also anticipating $50,000,000 of Bavarian chikungunya vaccine approval milestone payments in the next thirty days. As we execute on our 2025 turnaround, initiatives, we will strive with the highest 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.

Operator, if we can open the lines for your questions, please.

Our first question coming from the line of Jessica Fye with JPMorgan. Your line is now open.

Hey, 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 naloxone 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? Just how much share you expect in 2025 relative to 2024? And any guidance on maybe additional pricing pressure in that market?

Sure. Try to take the first part of it and go without the fill in some other parts, but go ahead. Okay.

All right.

Thanks, Nick.

Appreciate the question. So we've talked about on our last call how the pricing first half versus the second half was differential, but that we had seen stabilization in the pricing in the second half. We broadly seen that continue as we've come into this year. Having said that, there we do expect there to be a follow through impact of that reduction in pricing that we saw in the second half to impact full year results. Would say that is the biggest driver of the guidance as we go forward into '25 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. And I think that's those are the comments that we'll make at this point.

Sure.

Maybe just I think, yes, one other point. Public interest, I think about 75% of our our total business, I think, was one of the questions you had answered in there as well. But I think, Rich, Great. And then maybe on here, just one more You guys are guiding to adjusted EBITDA in 2025, but roughly flat year over year at the midpoint.

I know you kind of commented on 2025 guidance, you're kind of representing a trough, 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're seeing Yes. Well, I think one of the great things we're doing now as we think about the businesses, we're have a diversified business where you've got a number of different assets, obviously with metamaterials in Narcan and now Klaxato. As I think Rich mentioned, I mentioned that we continue to look to do some additional business development opportunities 2025 and beyond. So I think it's really those all of those that will contribute to the overall opportunities for growth in our adjusted EBITDA. Obviously, we're not going to say anything specifically about the 2026 yet. I think it's going to be the diversification of our portfolio the additional organic opportunities we have with we're doing with Tempexa, what we are doing with the Ibanga 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 for GIP would be an upside for us if we're fortunate enough to get that business.

So those are all the things that we think will help drive the in internal opportunities for '26 [indiscernible] external or business development side, got certainly Clarksado, what we're 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 which we will pursue for additional business development. But that was the reason probably the amazing I'd add to the twenty twenty Great. Thank you. Hey, Abri, next question please.

Our next question coming from the line of Brandon Folkes with Rodman and Renshaw. Your line is now open.

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 and A 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? Yes. 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 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. A. And I think you're seeing that and what Bridge was saying, but you look at what's happening with everything from the gross adjusted gross Emergent, just overall margins that we're expecting when you do it and operating reductions. I think all those are packaged together as how we're looking at the expenses we've been taking out of the business '23 and 2024 and now we're seeing the full year benefit of it in 2025.

Great. Thanks. And maybe just coming back to Klipsada, I hope I said that correctly. How are you going to position that relative to NARC? I know you mentioned sort of now that you own a some there are some users of it. I can see it obviously plugging into your distribution system. But do you expect to grow Clixoto By sort of positioning it in any way or really being a distribution driven growth story? First and foremost, when we acquired Cloxeta, we made comment that we think Clarksado 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 [indiscernible] work through our NARCAN direct distribution capability. So, at first and foremost, we think it's going to be easier to do business as we put together Klaxato with NARCAN 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 increase percentage of the overdoses out there. We think Klaxato may be appropriate for some of those ink fentanyl dosages are out there in the marketplace We want to make sure that if needed, we have Kloxado.

If needed, we have a standard of care with NARCAN. Either way, the first to make it easier for them to [indiscernible] get what they need 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 help all of our customers with it. So that's the primary way we'll do it. Average individual first responders always going to have to make the judgment as to whether or not they need a 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 glad to have that capability now with the Klox Auto transaction.

Great. Thank you very much. Thank you. Operator?

Next question please.

Our next question coming from the line of Raghuram with [indiscernible] This is Eduardo on for Ram. From H. C. Wainwright. I guess I was I guess we're talking about COOXADA.

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?

Yes. So we announced the transaction in January. And now we're working through all the logistics there currently. Obviously, Hikma has some products in the system already. So we're working through all the logistics now. And we expect to have it in next thirty to sixty days is when we'll have it going through our our ordering capabilities. You obviously want to make it easy for the first responders for them to order it to work through our system. So we're working through all those details to ensure that it's easier for the first responders to get the product in make it a value add for them, not make it a difficult process. So look, George, I have more to say about that in the the next thirty to sixty days.

Got it. That's really helpful. [indiscernible] Curious if the MOSA trial is still on track for its first interim the end of this first quarter.

So what we're doing with MPOX is we're working with World Health Organization specifically to get the emergency use [indiscernible] We expect to hear more from them sometime in the near future. Obviously, as we go through changes in administration, changes in [indiscernible] 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 on our ACM product. That's nothing specifically that going to talk too much about right now, but we do have additional Clinical trials are to work in a small underway in the smallpox area.

Understood. 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 X exercises under procurement orders for the BioDefense products? And if so, which ones?

Yes. 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. Government is going to continue to execute against those contracts and issue us procurement orders as we go through the year.

And 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 and just really the 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 New Year. Great. So much for the clarity. Thank you. And I'm showing no further questions in the queue. I will now turn the call back over to Mr. Joe Papo for any closing remarks.

Thank you, operator. Thank you everyone for joining us ladies and gentlemen. We everyone's attention to our earnings call today. Thank you for your participation. Please note in our version of today's webcast, as well as the PDF version of our slides used today. Be available on our website accessible through the Investors landing page of the company website. Thank you again for joining us. We look forward to speaking with all of you in the near future. A great day.

This concludes today's conference call.