Emergent BioSolutions Inc.

Good afternoon, everyone. I'm the operator for today's call. Thank you for joining today as Emergent discusses their operational and financial results for the second quarter 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 three. 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 except as required by law, emergent does not undertake to update any forward-looking statement to reflect new information, event, 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 four, the agenda for today's call will include Joe Papa, President and Chief Executive Officer, who will comment on the multi-year plan update, key product highlights, and future catalysts. Rich Lindahl, EVP and Chief Financial Officer, who will speak to the current state of the company, financials for second quarter, as well as 2024 full-year guidance, including guidance for the third quarter. This will be followed by Q&A. Finally, and for the benefit of those who will be listening to the replay of this webcast, this call was held and recorded on August 6, 2024. Since 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?

Hello, everyone, and thank you for joining us today to discuss our second quarter results in our 2024 financial outlook. I am joined today by Rich Lindahl, our chief financial officer. Following my opening remarks, Rich will detail our quarter two performance, provide guidance for the third quarter, as well as our full year guidance. I will then review our future growth drivers, providing summarizing thoughts on our multi-year plan, and then we'll open it up for Q&A. First, I would like to start by thanking our emergent team members. who have been hard at work executing on our multi-year plan to stabilize, turn around, and transform the business. It has been a great team effort in the first half of this year, and specifically our quarter two efforts enabled us to exceed our quarter two revenue guidance without a significant ACAM 2000 shipment that we were able to recognize in early July. I appreciate the dedication of our team, especially their support for our mission and our values. Turning to slide six, I'd like to review our progress against our multi-year plan focused on stabilizing emergent. Based on the first half performance, we are raising the midpoint of our 2024 revenue and adjusted EBITDA guidance, which Rich will walk through in great detail. While there are some one-time items in Q2 numbers, we made great progress against our plan, including making a significant reduction to our debt, as well as operating performance and working capital improvements. We focused on our product core business drivers and delivered for our customers and patients. We created a customer-focused, leaner, more flexible organization, and we streamlined our site network. And finally, leveraging our product and internal capabilities to support future growth. Turning to slide seven, I'd like to call out several activities that have been critical during the initial stabilization phase of our multiyear plan. We successfully amended our credit agreement, expanding the runway to execute on our operational plans.

Following our move, we will make our first restructuring announcement.

And after the transaction for our closest for our Kansas side, this quarter. Combined, we will have reduced our workforce by approximately 50% since January 2024. We will also have a total of approximately 110 million dollars in expense savings from these combined efforts. In July, we resolved our contract dispute with Johnson and received a $50 million payment from the settlement. We successfully completed an FDA inspection at the Kansas facility in July, which is a full GMP surveillance inspection of our biologic products. This underscores our commitment to ensuring the highest standards of patient safety and product quality. I thank the team again for all these great efforts. Now on slide eight, I walked through a series of strategic actions taken in the second quarter to reduce our total quantum of debt this year. On our previous earning calls, we discussed divesting certain products and assets. To date, we have achieved a $75 million divestment of RSDL to serve pharmaceuticals, $30 million from the sale of our Kansas facility to Bora Pharmaceuticals, which is expected to close this month and will result in a 350-person headcount reduction. The net proceeds from these two transactions is expected to more than satisfy the junior capital raise requirement under Emergence Amended Credit Facility. We also sold an empty, underutilized warehouse at our Canton site for $7 million. We received $50 million from Johnson following our contract dispute settlement, and we expect $10 million in third quarter related to Bavarian Nordic Milestone and anticipate another $20 million by year end. Also, we have generated operational cash flow following our main business update. working capital to contribute to debt pay down. Rich will have more comments on that. Turning to our product business slide on slide nine, we continue to make progress delivering on our commitments. I'll start with the key highlights around Narcan nasal spray. We are continuing to invest in the expansion of Narcan nasal spray, which is more crucial than ever as the opioid crisis continues. Last year, more than 100,000 lives were lost to a drug overdose, of which nearly 8 in 10 were caused by an opioid or a synthetic opioid. This is an unacceptable number of Americans' lives lost every year. As a leading Naloxone product, we are determined to increase access points of Narcan to help get the life-saving product into the hands of more people. And in Canada, where the opioids-related deaths continue to increase, we are working closely with health care providers to distribute convenience kits containing Narcan, which are critical to first responders and people in positions to help save a life. We also believe our efforts to broaden access and increase awareness are contributing to the impact we're seeing across several hard-hit areas. For example, states like New Jersey reported 1,007 suspected drug deaths in the first six months of 2024, but that's down 26% from last year. And Maine had an expected 12% decrease in opioid-related overdose deaths. While it's not promising to see the number of opioid deaths decreasing, unfortunately, opioid deaths still remain high, and we believe that expanding access to Narcan is needed. Annually, we expect to deliver Narcan to about 18,000 individual patients across the U.S.

and Canada through our Narcan Direct program. serve as the best provider to all of our public interest customers.

In fact, we announced just earlier today a new distribution center in Nevada. This new facility allows Emergent to further meet the increased demand for Naloxone by now having faster, more efficient delivery for Narcan to all of our customers. We continue to tackle the many barriers to increase consumer access by offering online availability through Amazon and pharmacy websites. We are creating an easy access avenue for the people who have an easy way to obtain delivered right at their doorstep. To date, we have distributed boxes of Narcan to 32,000 retailers. OTC status for Narcan has also enabled our business-to-business and workplace efforts. We have secured five major businesses that have ordered Narcan, including United States Gypsum, Coppers, and leading financial services companies, just to name a few. We launched Narcan.com Workplace, which enables businesses to order Narcan and have it shipped to their offices and worksites. We continue to engage with new partners, like the National Safety Council, to educate and reach businesses around the importance of workplace safety. And just last month, the American Medical Association shared their support to put Nalaxone next to defibrillators in public places. To pull on this thread, we understand that approximately 1,700 lives are saved by the defibrillators each year, and the device costs about $18 on average. We also believe putting Nalaxone, which is a fraction of the defibrillator cost, alongside this lifesaving measure could help tens of thousands of lives lost to opioid overdose each year. Our country is facing a public health crisis that has bipartisan support and continuous federal and state funding helps increase access to Narcan for first responders. Just last week, a study in Lancet reported that fatal opioid overdoses contributed to a lower American life expectancy by nearly a year The burden of these deaths and life expectancy and years of life lost is due to the high burden among younger adults. We clearly have more work to do here. In a new survey we conducted, it was found that younger generations aged 18 to 34 and those in high school level education were less likely to be aware Naloxone can reverse the effects of fentanyl, putting these already vulnerable populations at further risk. We will continue to strive to meet and respond to our customers' needs to ensure we maintain our leadership position. Turning to our medical countermeasures portfolio on slide 10, in addition to opioid overdose epidemics, we maintain a leadership position in addressing leading public health threats, including anthrax, smallpox, botulism, and Ebola. We are optimistic about the potential of our MCM products, including Convexa and Ivanga, and their ability to contribute to our future growth. This includes over $250 million in contract modifications with the U.S. government for our MCM business, including a $30 million order to supply Syphendis, $99.9 million to supply ACAM 2000, and new contract options totaling $122.9 million to supply U.S. government VIG and VAT. We believe that these milestones reaffirm our place as a trusted biodefense partner and demonstrate the strength of our total portfolio. Contracts also indicate continued runway for potential future procurement. In fact, we expect to receive approval from the FDA on our SBLA to expand ACM for MPOCs by the end of the quarter. We have a strong line of sight to future procurement levels for our existing portfolio and look forward to pursuing additional opportunities for contract awards in the second half of the year. Next on slide 11 is a look at our streamlined footprint of sites in Lansing, Michigan, and Winnipeg. This is driven by our previously announced decision to scale back our bio services work while maintaining our ability to manufacture and deliver our products to customers. We are winding down our efforts at Bayview and Rockville sites, further reducing our manufacturing footprint and our working capital. As mentioned, we sold our empty facility in Canton, Massachusetts for $7 million, which is demonstrative of our efforts to explore strategic alternatives for sites that are not linked to our core capabilities. In summary, on slide 12, we have a diverse portfolio of products linked to our manufacturing network that we expect will continue to improve The demand is both in the U.S. and abroad. I'll now hand it over to Rich to review our financials.

Thanks, Joe, and good afternoon, everyone. We appreciate you joining the call today. As Joe has just discussed, we're making significant progress against our near-term priorities of stabilizing the business and strengthening our financial foundation. Our report today reflects several key proof points. We delivered solid second quarter results with continued momentum of NARCAN, shipments of anthrax, and an international sale of ACAM 2000. We received over $250 million of contract modifications to continue supplying Sifendis, ACAM 2000, VIG, and VAT to the U.S. government. We announced a confidential settlement agreement with Janssen Pharmaceuticals, which resulted in a $50 million payment to Emergent on July 31st. We announced $112 million in asset sales.

We entered into a definitive agreement to divert

our Baltimore Camden facility to Bora Pharmaceuticals for $30 million, sold an underutilized warehouse at our Canton facility for $7 million, and sold our chemical decontamination product, RSDL, to CERB Pharmaceuticals for $75 million. These transactions, once fully completed, will satisfy the capital raise requirement in our amended credit facility. We received notification that the EMA accepted the Bavarian Nordic submission for the Chikungunya vaccine, which was part of the travel health divestiture in 2023. This acceptance triggers the first milestone payment of $10 million, which we expect to receive in the third quarter. We'll go into further detail on the balance sheet, but the influx of cash from these items is expected to provide approximately $200 million that can be used for debt repayment this year. Since the beginning of 2023, We have also announced actions to reduce annual expenses by roughly a quarter billion dollars. This reinforces our commitment to improving our overall financial foundation and setting the business up for stronger profitability and shareholder value going forward. And finally, we are again raising the midpoints of our revenue and adjusted EBITDA guidance for 2024. Turning to our results, we had another strong quarter with revenue above our previously provided guidance. As indicated on slide 14, highlights in the second quarter include total revenues of $255 million, a decrease versus the prior year due to timing of the U.S. government order for ACAM. Total segment adjusted gross margin of 26% versus 43% in the prior year, primarily due to the Janssen Settlement Agreement, the write-down of related assets, and other one-time charges. An adjusted EBITDA on the quarter of negative $10 million, a reduction versus the prior year due to the timing of U.S. government procurements and approximately $28 million of one-time charges. Turning to slide 15, you'll note there are a number of non-recurring items in our results for the quarter, many of which are added back as seen in the non-GAAP reconciliation tables. A common theme here is that as part of our efforts to stabilize, turn around, and transform the business, We have taken several decisions that improve our future profitability but result in short-term charges. In particular, our actions to reduce our site footprint and significantly de-emphasize our bioservices business required us to evaluate the related asset values, which in turn led to the impairments and write-offs shown on the slide. We also resolved several legacy issues and now move ahead with the uncertainty of those matters behind us. Diving deeper into quarterly revenues, Important items on slide 16 include Narcan sales of $120 million, which reflects continued robust demand for our opioid overdose reversal product. Compared to the prior year, we had a slightly unfavorable price-volume mix in the U.S. public interest channel, partially offset by higher sales of over-the-counter Narcan. Anthrax MCM sales of $39 million, an increase of $18 million versus the prior year, driven by timing of Siphendis and BioTrack sales. Smallpox MCM sales of $18 million, representing the international order of ACAM 2000 in the second quarter. The decline year-over-year is due to the timing of the U.S. government procurement for ACAM 2000, which we delivered in early July. Other product sales of $7 million, a decrease of $13 million versus the prior year, primarily related to BAT and RSDL sales timings. and total bioservices revenues of $65 million, which includes the $50 million attributed to the arbitration settlement from Janssen. The remaining bioservices revenue in the quarter was primarily related to our Camden facility. Turning to operating expenses on slide 17, cost of commercial product sales in the quarter was $53 million, influenced by the continued strong sales of Narcams. Cost of MCM product sales in the quarter was $31 million, driven by sales of Cifantis and BioFrax. Cost of bioservices, up $212 million, reflecting the asset write-down related to the Janssen Settlement Agreement, offset by a decrease in overhead costs at our Maryland facilities. R&D expense of $33 million, which includes project termination costs and restructuring costs associated with the May 1st announcement. Outside of those items, our core R&D costs are currently focused on the funded IBANGA development program. An SG&A spend of $86 million, including restructuring costs offset by lower employee and marketing-related expenses. With that, let's move to slide 18 and review segment performance during the quarter. In the commercial segment, revenues were $120 million, comprised entirely of NARCAN, and segment adjusted gross margin was $67 million, or 56%. In the NCM segment, revenues were $63 million driven primarily by anthrax and an international sale of ACAM 2000. Segment adjusted gross margin was $35 million or 55%. As for the services segment, revenues were $65 million and segment adjusted gross margin was negative $36 million. I'll now take a moment to summarize our 2024 year-to-date performance as shown on slide 19. First half revenue was $555 million, up 11% versus prior year, driven by MCM and bioservices. Year-to-date adjusted gross margin was $213 million, or 39%, reflecting our prior efforts to reduce costs, as well as MCM sales timing, and first half EBITDA was $57 million, an improvement of roughly $100 million versus the prior year. Turning to slide 20, we ended the second quarter with $70 million in cash and $83 million of total liquidity, including availability under our revolving credit facility. And as of June 30, 2024, our net debt position was $794 million, a roughly $40 million reduction versus the first quarter. Networking capital was $380 million at June 30, a $53 million improvement versus the prior quarter. and $71 million lower than the second quarter of 2023. We remain focused on continuing to optimize our working capital position to free up capital for debt repayment. Turning to 2024 guidance, please see slide 21. While our efforts to improve operating performance will not happen immediately, we are making significant progress. As announced in our press release this evening, we're updating our outlook for the full year 2024. For both revenue and profitability, as we did in May, we are raising the midpoint of our revenue and adjusted EBITDA guidance. Four-year guidance is as follows, and the details are shown on slide 29 in the appendix. Total revenues of $1.05 billion to $1.125 billion. Commercial product sales of $450 to $480 million. We continue to see strong demand for Narcan in the U.S. public interest, Canadian, and OTC channels. Having said that, We're taking a more conservative view on 2024, given developments in the competitive environment. MCM product sales are $455 to $490 million. Since our last report on May 1st, we received the $250 million award for Sifendis, ACAM, BAT, and VIG. We now have a large portion of our MCM revenue committed for 2024. services segment revenue of $120 to $130 million, an increase versus our prior guidance due to the impact of the Janssen settlement. Shifting to profitability metrics, we're forecasting adjusted EBITDA of $140 to $180 million. The increase at the midpoint reflects the improved visibility of our MCM revenues, as well as our continued focus on operating expenses. It's important to note that this guidance reflects the sale of RSDL, which we completed last week, but does not yet reflect the impact of the upcoming Camden facility sale, as that transaction is not yet closed. Having said that, there is currently $15 to $20 million of revenue and negative $5 to $10 million of adjusted EBITDA related to Camden in our forecast for the second half of the year. For the full year of 2024, we're forecasting total segment adjusted gross margin of 42% to 45%. Shifting to the third quarter, we're forecasting revenue in a range of $265 to $315 million. That's all for the financial update. I'll now turn the call back over to Joe for some final thoughts.

Thank you, Rich. team at Emergent made significant progress executing on the strategic operational changes to stabilize our financial position and position as well for the future. This is critical to our turnaround. But as we look forward, we see meaningful opportunities for Emergent growth drivers to have the potential to impact lives around the world. Turning to slide number 23, I'd like to focus on the future growth drivers for our organization based on the potential expansion of our inline products. This will look like international expansion and line extensions of our current products, strategic partnerships that leverage our own capabilities or identify unique public-private partnerships, increased focus on public health preparedness, and funding and willingness to address the opioid epidemic. In closing, our transformation will take time. It's not linear, but that said, I'm pleased with the progress our team has made and the value created over the past month in a importantly, the debt pay down that we have achieved. We are planning to finish this year strong by paying down a significant amount of additional debt while we prepare to enter our turnaround phase and move towards an exciting future. With that, operator, let's open up the line for questions.

Certainly. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. And one moment for our first question. Our question will be coming from Jessica Phi of JPMorgan. Your line is open.

Hey, this is Nick on for Jess. Thanks for taking our questions. First, with the decision to expand Narcan distribution capabilities with the new center in Nevada, can you kind of talk about the long-term growth opportunity for Narcan in both OTC as well as the PIP market? Kind of how are you thinking about the overall market opportunity across OTC and PIP? What do you see as the current and future growth driver there? And maybe could you comment on potential peak sales for Narcan?

Sure. You got a lot of questions there. I'm also joined by Paul Williams, who's here, who can help us to address these questions. This is Joe Papa. I'll start, Paul, then feel free to add in. I think first and foremost, what we're most excited about is that this is a real public health problem and that we've got to solve it. We've got to help solve it. We believe Narcan... has shown some good progress in solving this. The fact I point to that there was a 3% reduction in total amount of deaths in the United States last year, but that still means there's a lot more to do when you're talking about still remaining 100,000 deaths. We think it's gonna get solved by a number of things. Number one, in terms of our ability to continue to expand access to Narcan, we believe that the amount of funding that will go towards the public interest market from some of the opioid drug settlement big pharma companies will come into this category, and that will help the states expand their educational program, but also the purchase and the ability to make NARCAN more available to all the markets, I think is first and foremost one of the big items for us. Beyond that, we clearly are working very closely with the states, and we believe that our NARCAN, our NARCAN direct programs are embedded into many of these public interest markets, and that's going to allow us, we believe, to continue to be a very important provider of Narcan to all those states. So I think that those are probably the first and foremost things I would add. We clearly believe the brand itself is a very important part of it. But, Paul, other things you want to add to answer that question?

Yeah, and maybe, Joe, I think a couple things. One is, I don't think you can understate the emphasis coming out of the White House, and we recently attended the Office of National Drug Control Policy Naloxone Roundtable discussion, where really talking about, we're barely just starting to see a decrease in deaths, but 100,000 deaths is way too much, and we've got to solve that, one, through the states, We've started to address that by expanding access with over-the-counter, which is going to allow us, I think, to expand into businesses. Obviously, we're online and on retail shelves and continue to drive a level of awareness and understanding around fentanyl poisoning, around accidental overdose, as well as in the addiction space. And I think all of those point to we've got a long way to go before Narcan, before we actually start seeing a plateau in the market and the demand for naloxone.

And I think what Paul is saying is what I think you have to comment on in the world we live in today. But the U.S. has bipartisan support for solving this problem. I mean, it's not often we get bipartisan support, but we do have bipartisan support for solving the opioid epidemic that we see out there right now. I think that's an important part of it. And I think one thing that doesn't get any further than the Lancet article that came out a week ago that says, the overall impact of opioid-related death is reducing the life expectancy of the United States population by almost a year, just because of opioids. That just says volumes about how important this issue is and volumes about why we believe Narcan can make a real difference. So I think that's what's going to help us with the growth. We clearly believe our distribution capabilities is why we added the Nevada distribution center, and we announced that today. It just allows us to be faster and more customer responsive, which is what we're trying to do for the future CREDA, and leaner, customer-focused organization that has more flexibility. So I think all those things are the reason why we see Narcan as being a great opportunity for the future.

Great. And with that in mind, a few months back, a competitor announced a distribution agreement with the state of California to supply OTC Narcan. How are you contemplating that with your current outlook for your OTC product? And are you seeing any other trends amongst other states?

We're working very closely. We still work very closely with the state of California to be clear. California had some very aggressive opioid reduction targets, which obviously we support the importance of that. We continue to supply products to the state of California. Once again, having a distribution center in Nevada makes it easier for us to deliver to the state of California. And we also believe that, as I said before, the NARCAN direct program is embedded into the public service process because we make it easier for them to essentially have a one-stop shop for getting access to our products. So we're going to continue to work with the state of California just like we work with the other states. We believe the brand market is important. We believe our manufacturing capacity and capabilities is important. And we believe our distribution capabilities to 18,000 locations around the United States are all very important reasons why we're going to be successful with the state of California, but for other states as well. And that's how we're approaching this in terms of we are the leader. We're going to continue to try to improve the overall access. And as that total market expands, we believe we're going to get our fair share of that market expansion as well.

Great. And maybe could you provide some additional detail on some of the steps you're taking to improve long-term margins and maybe provide some color on what you see as an achievable margin profile for the current business?

Are you asking specifically about Narcan or just total business?

Total business, but Narcan as well if you want to comment on that specifically. Okay.

Yeah, well, let me start with darkening because that's where the basis of your questions are. We are clearly working with our partners on the contract manufacturing of our product and continuing to work to reduce the total cost of goods sold for our product. We have a good understanding of what we can do, and we've already made some progress this year. We expect to, and we've targeted even more progress for the future, but we're working very closely to look at those specific vehicles in terms of where the cost is by what's the cost for the raw material, what's the cost for the actual nasal device, and then also the assembly, et cetera, looking at all avenues for Narcan to bring down that cost. I think on the rest of our business, Rich probably may wanna make some comments, but I think one of the things we're doing and looking at overall gross margin is just creating a leaner, more efficient network in terms of our manufacturing side. We believe that will give us significant reductions in our cost of goods sold just as we become more efficient at each site. As we talked about during the call, we're going to shut down the Rockville. We're shutting down the Bayview as we dive in. the Camden site, as we sell the Canton site, all those action steps we believe are going to help us with our overall gross margin improvement, and I think that's the way we'll mostly get to those relative savings over time. Obviously, each site, the remaining Lansing site, the remaining Winnipeg site will become much more important and obviously more, we believe, efficient as we go forward.

Yeah, I think that's right. So the major driver is really the cost that we've taken out in terms of the manufacturing site network so that we have less unutilized capacity or excess capacity in the network. That's really helping cost of goods sold as we come through the end of this year and into next year. And then we're being very disciplined about our R&D spending as we go forward. And then finally, on the SG&A side, We are working very hard to reduce our overall level of SG&A, which, again, will flow through as we come out of this year into next year.

Okay, maybe just the last one from us then. Could you provide some color when we should expect an option for Tbexa and Ibango?

So I think on IBANGA, that is still a few years out into the future, based on the nature of the contract, which really had several years of development and commercialization, or scale-up, I should say, followed by procurement options following that. On Tembexa, we continue to have conversations with the United States government about the timing and magnitude of the next option exercise. We don't have anything to report today, but we are working hard to maintain the continuity of supply of that product as we move forward.

Great. Thanks so much.

Thank you. Again, if you would like to ask a question, please press star 111 on your telephone and wait for your name to be announced. If you withdraw your question, please press star 111 again. I'm showing no further questions. I would now like to turn the call back to Joe for closing remarks.

Well, thank you again, everyone, for joining us today. As I mentioned on set, I'd like to thank our emergent team for all the great work during the quarter to help us to achieve the milestones we've achieved. Importantly, we look forward to finishing the second half of the year strong, continuing to pay down that we've already achieved. adding to that debt pay down, of course, and then importantly, continue to improve our overall operational performance for the business and reduce debt by the working capital improvement. So all those things will be important parts of our future. Look forward to any additional questions as we have a chance to go out and talk to all of you. Thank you. Have a great day, everyone.

Thank you all. And with that, ladies and gentlemen, we now conclude the call. Thank you for your participation. Please note an archived version of today's webcast as well as a PDF version of the slides used during today's call will be available later today and accessible through the investor's landing page on the company's website. Thank you again. We look forward to speaking with you all in the future.