Emergent BioSolutions Inc.

Good day and thank you for standing by. Welcome to the Emergent Biosolutions first quarter 2023 financial results conference call. At this time, all participants are in 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to the company. Please go ahead.

Thank you, Jada, and good afternoon, everyone. My name is Bob Burrows. I'm Vice President of Investor Relations for the company. Thank you for joining us today as we discuss the operational and financial results for the first quarter of 2023. 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 slides three and four, during today's call, we may make projections and other forward-looking statements related to our business, future events, our prospects, or future performance. These forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events. Any forward-looking statement speaks only as of the date of this conference call. And, as accepted as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the SEC when evaluating our forward-looking statements. During today's call, we may also refer to certain non-GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding emergency operating performance. Please refer to the tables found in today's press release and in the slides regarding our use of adjusted net income and loss, adjusted EBITDA, and adjusted gross margin, and the reconciliations between our GAAP financial measures and these non-GAAP financial measures. Turning to slide five, the agenda for today's call will include Bob Cramer, President and Chief Executive Officer, who will comment on the current state of the company, Paul Williams, SVP and Head of the Products Business, who will comment on the state of the Nellie Kahn nasal spray franchise, as we migrate to our non-prescription form of this key medical countermeasure. And Rich Lindahl, EVP and Chief Financial Officer, who will speak to the financials for Q1 2023, and then pivot to our revised forecast for full year 2023, as well as Q2 2023 total revenues. This will be followed by a Q&A session where additional members of the executive leadership team are present and available as needed. Finally, and for the benefit of those who may be listening to the replay of this webcast, this call was held and recorded on May 9, 2023. 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 Bob Kramer. Bob?

Thanks, Bob, and good afternoon to everybody. Thank you for joining the call. My comments this afternoon begin on slide six. Our first quarter performance was generally in line with expectations as revenues came in above our guidance range but were offset by higher than expected operating costs that had a bearing on our profitability for the period. And Rich will provide more detail in his prepared remarks. We continue to strengthen our core businesses and build a foundation for sustainable long-term growth. And today, I'd like to walk you through some of the progress since the beginning of the year and where we're going to go for the rest of 2023 and beyond. First, we expect the sale of our travel health business to Bavarian Nordic to close as planned in the second quarter of this year. Upon closing, the deal will provide an upfront cash payment of approximately $270 million and a potential additional $110 million in sales and development-based milestones. As I said when we made this announcement earlier this year, this deal achieves two significant outcomes. First, it allows us to further sharpen our focus on our core products and contract manufacturing services businesses while allowing continued supply of these important vaccines to patients and customers. Second, and before discussing Narcan nasal spray in more detail, I'd like to mention that today is Fentanyl Awareness Day. Every day, the opioid epidemic cuts short innocent lives. This epidemic shows no signs of abating, and we remain committed to working with federal, state, and local governments and advocacy groups across the nation to ensure more naloxone reaches communities, patients, and those in need to help reverse the trend of increased opioid-related overdose deaths. That's one reason why we view the FDA's approval of our application to make Narcan nasal spray the first and only opioid reversal treatment approved for over-the-counter use as a significant step forward in our efforts to expand access and availability of this life-saving medicine. Since acquiring the product in late 2018, we've consistently supported efforts to expand awareness of and access to naloxone. We've also maintained our commitment to affordability and support for public interest partners who often are responsible for responding to opioid overdose emergencies. We believe greater access to Narcan nasal spray as a result of the OTC designation will help save countless lives. As we said following approval, we're targeting a late summer launch for the OTC product and are in discussions with potential retail partners to support this critically important initiative. We continue our commitment to making Narcan nasal spray affordable while pricing the OTC product in a sustainable manner to support our continuous manufacturing, and unique distribution capabilities. As a result of the ongoing epidemic, we're seeing continued growth in demand from the U.S. public interest channel as well as in Canada. Paul Williams, our senior vice president of the products business, will join us today to provide more details about Narcan following my remarks. Third, we continue to sustain a strong partnership with the U.S. government focused on preparedness and response into helping provide medical countermeasures for the public health threats it has identified and prioritized. With respect to our smallpox franchise, we recently received a notice of intent to procure ACAM2000, our smallpox vaccine, for delivery in 2023. This follows a similar notice of intent to procure for our VIGIV therapeutic product, The exact details are not yet final, but the values for each are reflected in our guidance for smallpox. Similarly, we've also received a notice of intent to procure our botulism antitoxin or BAT product, which is reflected in the other products guidance. These notices demonstrate our continued support of and partnership with the U.S. government as they seek to address potential public health threats. These would be the second, third, and fourth contract awards in the last six months following the January contract announcement earlier this year with the U.S. Department of Defense to procure RSDL. With respect to the biologics license application or BLA for anthrax vaccine candidate AB7909, we continue to have constructive engagement with the FDA and believe that we remain on track for the PDUFA date in July. We're working closely with the government to transition this product to post-exposure or post-approval procurement. As a reminder, in 2019, AB 7909 was the subject of a pre-emergency use authorization package submitted to the FDA, and since then, the US government has been procuring this product for placement into the Strategic National Stockpile. These actions are consistent with the repeated comments and budget recommendations from the Department of Health and Human Services and specifically the Assistant Secretary for Preparedness and Response about the necessity of maintaining America's preparedness and response capabilities. As we've noted previously, government contracting does not always work on the schedule private industry sets or suggests. Understanding that, we remain confident in the value placed by the US government in maintaining domestic medical countermeasure manufacturing capabilities in the important role of public-private partnerships in addressing known and unknown public health threats. Fourth, we continue to implement our strategy of improving and strengthening our quality and compliance infrastructure and culture. While not largely visible externally, This work is fundamentally critical to our success in delivering for our current customers and ensuring both our products and services businesses are positioned for sustained growth well into the future. And finally, we're actively managing our business and the balance sheet to improve efficiencies while securing and maintaining sufficient liquidity and access to capital. We've completed the organizational changes announced in January. which are expected to result in approximately $60 million in annualized savings. The anticipated sale of the tribal health business will provide an additional $270 million in cash proceeds, and we're actively working with our lenders to restructure and extend our debt obligations. We expect to have an agreement in place by May 17th of this year. I've said it before, but it bears repeating. While our strategy is already driving improvements, The full benefits of the actions we have taken in a plan will not be realized overnight. For 25 years, emergent has been at the forefront of helping protect Americans from serious public health threats. Our intention is to continue doing so for another 25 years and more, and the actions we're taking will help make that a reality. With that, I will now turn the call over to Paul to speak briefly about our plans for Narcan nasal spray before Rich shares more on our financial performance for the first quarter of this year. Paul?

Thanks, Bob, and hello, everyone. My comments are summarized on slide 9 and 10. As Bob noted, the ongoing toll of the opioid crisis remains top of mind for all of us at Emergent. We take seriously our responsibility to work with all stakeholders in developing solutions to help those who experience an opioid overdose get a second chance. That is why we see the approval of Narcan nasal spray to be sold over the counter as a historic milestone in the fight against the opioid crisis. It allows Emergent to make Narcan nasal spray available through pharmacies, convenience stores, vending machines, online retailers, and anywhere else OTC products can be found. This is a significant opportunity to expand access and build on our continued commitment to our public interest partners across the country. With our FDA approval, we can now move forward confidently with our plans. First, we are meeting with retail partners to finalize contracts and distribution plans. While I'm not in a position to share specifics at this time, suffice it to say these are the partners you'd expect. As we announced in April, we are targeting a consumer out-of-pocket price of less than $50 a box of two four-milligram doses. This is significantly lower and the currently available prescription wholesale price of $125 for a box of two. Second, currently our supply chain manufacturing efforts are focused on supporting the new OTC configuration with the goal of having product on shelves by late summer. We are confident we have the capacity to fulfill demand across all channels. And importantly, as we transition our existing packaging and manufacturing to support OTC use, four milligram Narcan nasal spray will remain in readily available supply through current channels. Third, we remain committed to working with our public interest partners, including providing innovative solutions for organizations lacking large-scale logistical support to ensure Narcan is available to the underserved communities who need it. Public interest partners are critical to maintaining the broad access to Narcan nasal spray. And lastly, we continue to seek new ways to serve markets outside the United States, namely in Canada, where the need for opioid overdose treatments continues to grow. This is reflected in our revised guidance for 2023. As Bob stated, Narcan nasal spray is the first and only opioid overdose reversal medicine approved for over-the-counter. And while we expect competitive entrants in the market, we don't expect those until early to mid-2024. Since its introduction in February of 2016, more than 44 million doses of Narcan have been distributed in the U.S. and Canada, and as a result, have given countless people a second chance. Sadly, the need for naloxone continues to grow. We believe Emergent is in a strong position to continue meeting that need based on our record of reliable service to our customers. We are excited about the opportunities to expand awareness of and access to Narcan that the OTC designation creates. We look forward to providing additional details regarding our pricing and our go-to-market strategy closer to launch in late summer. With that, I'll turn it over to Rich.

Thank you, Paul. Good afternoon, everyone. We appreciate you joining the call. I'll start on slide 12 and touch on a few key financial highlights before walking through the first quarter details. First, as Bob noted, we anticipate closing on the divestiture of the travel health business in the second quarter. which will provide an infusion of upfront cash while furthering our stated objective of sharpening our strategic focus. The impact of the sale is now incorporated into our updated guidance for 2023 and enables us to better align our cost structure with our current revenue trajectory. Second, as you heard from both Bob and Paul, we continue to see robust demand for Narcan nasal spray in both the U.S. public interest and Canadian markets. and that is reflected in our first quarter results. These trends are leading us to significantly increase our NARCAN revenue guidance for this year. In addition, our NARCAN guidance also continues to reflect our assumptions regarding the impact of over-the-counter sales, which we are planning to initiate beginning in late summer. Third, the U.S. government has recently provided us with notices of intent to procure quantities of ACAM, FAT, and VIG that all align with our prior expectations. Fourth, we are adjusting down our CDMO revenue guidance, driven principally by recent changes to customer requirements for COVID-related products we were manufacturing. These impacts, along with continued remediation costs and other investments to improve quality and compliance across our entire manufacturing network, negatively affected first quarter adjusted gross margin and have a corresponding ripple effect on our updated full-year adjusted gross margin forecast. Calendar 2023 will continue the process of rebuilding this business, readying our manufacturing capacity and positioning it for growth in the future. Lastly, we are in the final stages of reaching agreement with our bank group to amend certain terms of our credit facility, including an extension of the October 2023 maturity date. We anticipate closing this amendment on or before May 17th, and we'll provide additional details at that time. With that, Let's now turn to a review of our financial results, which can be found on slides 13, 14, and 15. Highlights include total revenues of $165 million, a decrease over the prior year driven by lower sales of our key medical countermeasure products and substantially reduced CDMO services revenue offset by better than anticipated NARCAN sales in the quarter. And as expected, Our key profitability measures declined versus the prior year, with net loss of $183 million, adjusted net loss of $159 million, and adjusted EBITDA of negative $101 million. Notable revenue elements in the quarter include anthrax MCM sales of $22 million, lower than the prior year due to timing of deliveries of AB7909 and BioFrax to the U.S. government's Strategic National Stockpile, offset by increased sales of anthracil. Narcan sales of $100 million, higher than the prior year, demonstrating the continuing durability of this product, driven by consistently strong demand from the U.S. PIP channel and the growing market in Canada. Smallpox MCM sales of $7 million, lower than the prior year due to timing of ACAM 2000 international sales. Other product sales of $14 million, slightly higher year-over-year, reflecting increased sales of Vaxcora and VivoTeef. as well as the timing impact of several other products, and combined CDMO service and lease revenues of $15 million, significantly lower than the prior year due to lower production activities in certain of our sites as we continue to support existing customers and rebate find the business following our COVID-19 response. Turning to operating expenses, Cost of product sales in the quarter were $103 million, higher than the prior year and driven primarily by lower overhead absorption combined with higher allocations of product COGs at our Bayview facility, offset by lower period costs at our burn facility and lower Narcan royalty costs. Cost of CDMO was $52 million, significantly lower than the prior year due to reduced production across the CDMO network, partially offset by higher costs at the Camden site resulting from additional investments in quality improvement initiatives. R&D expense of $41 million, lower than the prior year due primarily to lower spending on the CHIC program, and SG&A spend of $101 million, higher than the prior year largely due to professional services supporting transformation activities and one-time costs related to the previously announced employee reductions. With that, let's move to slide 16 and review segment performance during the quarter. In the product segment, revenues were $143 million. A decrease in the prior year as strong performance from Narcan was offset by lower contribution from both Anthrax MCM and Smallpox MCM sales. An adjusted gross margin was $44 million, or 31%. Both decreases over the prior year, reflecting lower sales volume, a less favorable product mix, and the higher cost of product sales I just discussed. As for the services segment, revenues were $15 million, a significant decrease from the prior year, and adjusted gross margin was negative $37 million, a decrease versus the prior year driven primarily by declining services revenues related to the COVID-19 response, coupled with incremental costs associated with facility remediation efforts and investments in quality and compliance across our manufacturing network. Moving on to slide 17, I'll touch on select balance sheet and cash flow highlights. We ended the first quarter with $430 million in cash, down sequentially from December 31st. Operating cash flow was negative in the quarter, due primarily to lower MCM and CDMO revenues. As we said previously, we expect the contribution of revenues, earnings, and operating cash flow to be weighted to the second half of the year. Capital expenditures in the period were $15 million, and as of March 31st, our net debt position was $975 million. Please turn to slides 18 and 19 for a review of our 2023 forecast and associated assumptions. As announced in our press release this evening, we're updating our guidance for full year 2023 as follows. Importantly, our revised guidance reflects the impact of the previously announced sale of our travel health business to Bavarian Nordic, which we anticipate to close in the second quarter. Total revenues of $1.1 to $1.2 billion unchanged from prior guidance. Anthrax MCM sales of $260 to $280 million, also unchanged from prior guidance. Narcan nasal spray sales of $360 to $380 million, an increase over the prior guidance primarily reflecting robust demand from the U.S. public interest channel and the Canadian market. Smallpox MCM sales of $235 to $255 million, unchanged from prior guidance. Other product sales of $120 to $140 million, lower than prior guidance, primarily reflecting the removal of travel health products following the anticipated completion of the divestiture. CDMO services revenue of $90 to $110 million, a decline from the prior guidance range for the reasons I highlighted earlier. Adjusted net loss of $85 to $35 million, slightly lower versus the prior range, reflecting the impact of higher Narcan sales and the impact of the travel health divestiture, offset by lower CDMO revenues and an increase to our tax valuation allowance. Adjusted EBITDA of $100 to $150 million, higher than the prior range, primarily reflecting the impact of the travel health business divestiture, as well as the upward revision to NARCAN, offset by the ongoing process of re-baselining the CDMO business. An adjusted gross margin of 39 to 42%, slightly lower than the prior range and reflecting the impact of overall revenue mix. Finally, we are guiding the second quarter revenues of $210 to $230 million, further emphasizing our anticipation that revenues and profits in 2023 will be more heavily weighted towards the second half of the year. To conclude, please turn to slide 20 for some summary comments. Our results in the first quarter once again reflect a mix of strong performance in certain core areas of our business, offset by ongoing challenges in other aspects of our business. We are committed to sustaining revenue growth and improving profitability, and we are addressing near-term challenges to our credit profile. Finally, as always, we remain confident in the impact we are having on patients and customers focused on health security and pandemic preparedness. That completes my prepared remarks, and I'll now turn the call over to the operator so that we can start the question and answer session. Operator?

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to 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. Our first question comes from Jessica Fai of JP Morgan. Your line is now open.

Hey guys, this is Nick on for Jess. Thanks for taking our questions. I had a quick clarification question on the Narcan guidance. You guys talked about the increase in that guidance from 290 to 310 to 360, 380. Is that, I know you talked about some of the push and pulls there and what drove that increase, but can we talk a little bit about how, if it's primarily due to an increase in demand from the public interest markets, Canadian markets? or is there also kind of more upside when thinking about OTC as well? Just thinking about those three together, kind of what drove that increase?

Yeah, Nick, this is Bob. Thanks for the question, and thanks for joining the call. I'll invite in a minute here Paul to weigh in, but as we announced our guidance initially for 2023, you know, we made it clear that Our plans included an OTC switch sometime in Q3 of this year. So the guidance that we initially provided that 290 to 310 number already had kind of consideration for OTC switch in it. I think what you see in our upgraded guidance now of 360 to 380 is primarily driven by what we see as increased demand. in the two channels that we're distributing product today, primarily driven by, again, the public interest market in the United States as well as Canada. But, Paul, weigh in here with some additional color.

Yeah, thanks, Bob. And, Nick, I know the increase in guidance is directly attributable to both the U.S. PIP segment as well as the Canadian segment. I think for the public interest segment in the U.S., obviously, given they serve just the – you know, the many vulnerable at-risk populations with the obviously continued increase of the opioid crisis, the demand flowing through that channel continues to grow and expand. And similarly, in Canada, you know, we're seeing expanded access to meet the demand in Canada as well. So, obviously, the update and the guidance, I think, reflects, you know, the trends that we are seeing as we start the year this year.

Great. Thank you. And just maybe a quick follow-up. Can you provide a bit of color on some of the conversations you've been having regarding potential insurance coverage for Medicare and Medicaid patients for OTC Narcan?

Yeah. Paul, you want to take that one?

Right. So, I think for us, you know, access is critical. I think that's what moving Narcan to over-the-counter is, I think, will really help and assist. But I think our conversations and working with whether that's CMS or private payers to understand how they're going to think about potential coverage for Narcan OTC continues. I don't think we've landed anywhere with any one particular payer or CMS yet, but we know that this is, you know, top of mind for them. We continue to work with them and other stakeholders to ensure that we're able to balance the access with the affordability as we bring Narcan OTC to market.

Great. Thanks so much.

Thank you. Please, as a reminder, please limit yourself to one question and one follow-up. One moment for our next question. Our next question comes from Brandon Foulkes of Kantar Fitzgerald. Your line is now open.

Hi, thanks for taking my question, and thank you for the update, Trey. Maybe just firstly, staying on Narcan, How do you think about the potential for a non-profit player to come into the OTC market there, both from perhaps the price, ability to supply and other factors? And, you know, if they do come to market, do you think it's a bigger, to become a bigger player in the retail first responder market there? And then along the line, you know, stay on that line of questioning. What can you say about a four milligram naloxone intranasal compared to perhaps a three milligram? Any data out there suggesting there are different different solutions or perhaps efficacy of the two products.

Yeah, thanks, Brandon. So, again, I'll start and then invite others to join in here as well. So, as it relates to your question about a potential nonprofit player in the nasal naloxone mix, and I'm not going to speculate, Brandon, on who might be out there and what they might be doing. Again, our focus continues to be as it has for the last five years, continue to look for opportunities to expand awareness, expand access, and as Paul indicated, continue to work with both public and private insurance companies to make this as affordable as possible. So I think the moves that we're making will make a big dent in that. In terms of a nonprofit, again, I think we won't speculate on what they might do. In terms of the four milligram formulation, I don't know that there are any exact studies comparing three versus four milligram. I think it's pretty widely accepted that, again, given the work that the FDA did on this product to approve it back in February of 2016, the four milligram presentation is widely accepted as a very safe and effective dose. Paul, if you want to add some more additional color, please do so. I think you got that one, Bob.

Great, thanks. And if we can count that as one question, just one follow-up. So just the intent to procure on ACAM 2000, can you just, and I apologize if you just explained it from the call, I'm popping between a few here. What does that mean versus the actual excise of a contract option? Are there any additional steps between that? to procure any ex-files of the contract option. And that's it for me. Thank you very much.

Yep. Thanks, Brandon. So, you know, the notice of intent to procure is what the government typically uses as the next logical step. So after they do a request for information and after they do a request for a proposal and a contractor responds to that RFP, then negotiations ensue. And after those negotiations are pretty much done, Brandon, you would typically see a notice of intent to procure. So while the exact details of the potential procurement that we refer to under the notice of intent to procure, we're not detailing now, they have been pretty much heavily negotiated. And we expect that the contract modification to be executed in a fairly reasonable time period. And as such, it's now baked into our smallpox franchise guidance for 2023, which is unchanged from earlier this year.

Should we go on to the next question, Jada?

Yes, of course. Thank you. One moment for the next question. Our next question comes from Boris Peeker of TD Cohen. Your line is now open.

Hi, thanks for taking the question. This is Nick on for Boris. Just a quick one for me, but how does the closing of the deal with Bavarian affect the income statement? Because I know that you guys raised EBITDA guidance without really changing it too much else directly affecting it. So, I was just wondering how this deal with the variant will affect that. Yep.

Thanks for the question, Nick. Rich, you want to take that one?

Sure. Happy to. So, we have incorporated the impact into our guidance, assuming, again, a Q2 closing. The main impacts are that the other products revenue will decrease because the existing VexCorp AvivoTeeth products will come out of our sales channel and move to Bavarian Nordic. In addition, there will be a positive impact on adjusted EBITDA driven primarily by lower R&D expense as the CHIC program spend will also transition over to Bavarian Nordic as well. So those are the contours of, you know, of what the impacts are going to be. We do not disclose, you know, the components of adjusted EBITDA below the total company level or the components of other product revenue, but those are the categories that are impacted.

Got it. Thanks. And then just a quick follow-up on that. So once the, assuming the deal closes in 2Q, Will then everything related to CHICB, VLPB sent over to them, there will be no more R&D costs from you guys on that? Or will you still have to finish out the phase three trial on your expense and then Bavarian takes up from there?

You know, they'll assume responsibility for the trial going forward.

Got it. Thanks very much.

Thank you. One moment for our next question, please. Our next question comes from Christopher Sakai from Singular Research. Your line is now open.

Thanks. This is Asim for Chris. I see that you have increased the guidance on ARCAN 29310 to 36380. And maybe coincidentally, there is also a decrease in gross margins of 4144 to 3942. And obviously, to an extent, you can give us color, you know, how much of the decrease in gross margin is due to Narcan, because I also see that another major development is travel health divestment.

Yeah, thanks for the question. Rich, you want to field that one?

Sure, yes. And you're right, there's several moving parts, I would say. The biggest influence on gross margin guidance change is the change in CDMO revenue guidance and the impact there, as well as, as I referred to on the call, just the impact in the first quarter itself of some of the activities there. So those are really the things that are driving the change to full-year adjusted gross margin guidance.

And as a follow-up, between now and what we call fourth quarter, depending on your conversations with the different channel partners and pricing and volume variables, it looks like, and correct me if I am wrong, that your expectations in terms of what you would be able to charge for Narcan's retail price versus, you know, what would be at your end has probably not changed. Do you think that assumption is correct?

So, Paul, you want to weigh in on that one? Sure.

So, I think, and thanks for the question, by the way. I think as we've communicated, we've targeted a consumer out-of-pocket price for OTC to be slightly less than $50. And I would say that is consistent with the price in the public interest segment as we go forward. So, again, we are in the process of finalizing our contracts with our retail partners. I would say as stakeholders in this, they're as committed to affordability as we are. And once those contracts are finalized, we can provide, you know, specific clarity on where the actual consumer out-of-pocket price will end up. But I think our goals are aligned in terms of affordability.

Thank you.

Thank you. We see no further questions at this time, and I will now turn it back over to the company.

Thank you, Jada. 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 Investors Landing page on the company website. Once again, thank you, and we look forward to speaking to all of you in the future. Have a good night.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.