8/1/2022

speaker
Operator

Thank you for standing by and welcome to the Emergent BioSolutions second quarter 2022 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Bob Burrows, Vice President of Investor Relations. Please go ahead, sir.

speaker
Bob Burrows

Thank you, Jonathan, and good afternoon, everyone. Thank you for joining us today as we discuss the operational and financial results for second quarter 2022. As is customary, today's call is open to all participants, and the call is being recorded and is copyrighted by Emergent File Solutions. 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 of the date of this conference call and, except 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 emergence operating performance. Please refer to the tables found in today's press release regarding our use of adjusted net income, 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, and Rich Lindahl, Chief Financial Officer, who will speak to the financials for QQ 2022, which will also discuss the updated 2022 guidance. This will be followed by a Q&A session where additional members of the executive leadership team are present and available as needed. Finally, for the benefit of those who may be listening to the replay of the webcast, this call was held and recorded on August 1, 2022. Since then, Emergent may have made announcements related to topics discussed during today's call. With that introduction, I would now turn the call over to Bob. Please proceed, Bob.

speaker
Jonathan

Thank you, Bob, and good afternoon, everyone. Thank you for joining the call. I want to provide you with a recap of our accomplishments last quarter and update you as well on our year-to-date progress. My comments are summarized on slide seven of the deck. The evolving COVID-19 pandemic, the war in Ukraine, the declaration of monkeypox as a public health emergency, and the ongoing opioid overdose epidemic further highlight the crucial need for an all-hazards approach in preparedness and response. These events underscore the importance of early and consistent investments in developing, manufacturing, and stockpiling medical countermeasures before a crisis occurs. They also serve as a reminder of the critical role that public-private partnerships play in protecting public health. This is core to what Emergent has done over the past 24 years, and our commitment to supporting preparedness efforts remains steadfast. This commitment is reflected in our strategic vision focused on public health threats and where we can make a positive impact for patients and for our customers. As we reflect on the second quarter and the first half of 2022, a few things we highlighted last February have become more clear. First, our medical countermeasures business remains a cornerstone of our strategy and a steady, proven contributor to revenue and profitability. Our relationship with the U.S. government is strong and growing as we explore and pursue additional opportunities through strategic partnering, M&A, and grants and contracts, as evidenced by our Tembexa and IBANGA announcements earlier this year. we also continue to see growing interest and demand from allied governments and organizations outside the United States. Secondly, the ongoing opioid overdose epidemic remains a very serious public health threat. As such, market demand for nasal naloxone products, primarily driven by Narcan nasal spray, continues to increase, resulting in performance at or beyond our expectations, even as generics continue to enter the market. Third, 2022 shaping up as a re-baselining year for our CDMO business and a return to our pre-COVID focus on our molecule to market offerings, namely through leveraging our expertise in development services to drive drug substance and drug product manufacturing. Fourth, we're making considerable progress in our product pipeline, including the acceptance for review of our BLA for 87909 and our ongoing chikungunya vaccine candidate phase three trials. You may note in particular that our phase two persistence data for this chikungunya candidate was published in the Lancet recently. We also continue to make good progress around advancing our earlier stage programs, including the initiation of phase one trials of our universal influenza vaccine candidate, as well as our therapeutic product candidate for side-night poisoning. And finally, quality and compliance are critical to our operations at Emergent. We're doubling down on strengthening our culture of quality and compliance with ongoing programs to ensure we're meeting both our regulatory requirements and our own high standards. Taking a closer look at each of the business lines, First, across our medical countermeasure and government products business, we see continued momentum. We continue to supply anthrax vaccine to the U.S. government under the existing 18-month option exercise valued at approximately $400 million, thereby ensuring product availability while the FDA reviews our BLA submissions. We've been given a PDUFA date of April of 2023, so assuming everything goes as planned, we expect their review to be completed by then. Turning to smallpox, we anticipate the U.S. government to exercise the next contract option for AKM 2000 this quarter, the latest component under our 10-year, $2 billion procurement contract. The HSR Act review period for the Timbexa acquisition has expired and Chimerix is anticipating a procurement contract from BARDA in Q3 of this year. Once the contract is awarded, we expect to close on the deal shortly thereafter. Relatedly, we are also closely following the Monkeypox public health emergency and public comments by government and health officials about the distribution and use of ACAM2000 as part of vaccination plans though it is not indicated for use against monkeypox. As we have for more than 20 years, we're working with the U.S. and allied governments and organizations to support their public health preparedness needs across a wide array of threats. As we announced in July, we're excited to add Ibonga, an FDA-approved monoclonal antibody treatment for infection caused by Ebola virus, to our portfolio of medical countermeasures. Our collaboration with Ridgeback Biotherapeutics makes Immersion responsible for the manufacturing, sales, and distribution of Ibanga in the U.S. and Canada. Ridgeback Bio will remain the global access partner. In our commercial products business, the opioid overdose epidemic continues to be a serious issue, and our focus remains on increasing awareness of and access to nasal naloxone. As mentioned earlier, Narcan and our nasal naloxone sales are on track through the first half of this year, led by increased market demand and resilience in the US public interest and Canadian markets, but offset in part by the continued decline in market share in the United States retail market with the introduction of generic competition. As expected, the second generic entrant is adding pressure to market share and pricing including in the public interest market. Our revenue guidance takes into consideration the maturing impact of generic competition and the anticipated increase in naloxone market demand given the continuing dynamics of the opioid crisis. As we're now seeing a return to global travel, we've restarted sales of VivoTeef in North America and in Europe and are in the process of relaunching VaxCora in the United States and launching Vaxcora in Europe. Turning to contract development and manufacturing services, we're in the early innings of transitioning this part of our business from a very heavy focus on COVID response during 2020 and 2021 to where we originally planned to take the business when we established our 2020 through 2024 strategy late in 2019. This transition includes the following key elements. Number one, winding down the majority of our COVID response work, including the activities previously performed in support of Janssen at one of our drug substance facilities. Secondly, operationalizing the significant capital investments in drug substance and drug product capability and capacity expansion at several of our other sites during 2020 and 2021. And finally, stepping up our longstanding commitment to quality and compliance across our enterprise network. Let me say a few words on each of these important initiatives. With respect to winding down our COVID work, our expectation is to have a significant portion of the Janssen wind down work completed by the end of Q3 and are hopeful for a timely contract resolution. Following the end of that work, we'll turn our attention toward resuming our internal product development and manufacturing at Bayview. A decision on which product may go first into the facility following the conclusion of the Janssen activities has not yet been finalized. Over the past 36 months, we've expanded and upgraded our capabilities, including installing and working to qualify state-of-the-art high-speed fill finish lines and improving drug substance manufacturing flexibility. Few of these investments were contemplated when we established our 2020 through 2024 strategic plan at the end of 2019. While these new investments will take time to fully operationalize, they give us reason to be bullish on the future of the CDMO business and our molecule to market service offering we adopted pre-COVID. Third, and building on my earlier comments regarding our commitment to quality and taking lessons learned from the pandemic response, We're investing in strengthening quality and compliance across all of our sites. This includes our previously discussed work at Bayview, as well as planned maintenance and upgrades at our Winnipeg and Camden sites. In addition to enhancements driven by our own quality standards, the FDA last inspected our Camden site in February of this year. They provided some comments that we have incorporated into our investment plans and have indicated that additional feedback will be forthcoming. While we await that feedback, we're performing additional reviews of the facility with a third party to provide further oversight of manufacturing and product release processes. This is a proactive step to ensure compliance and delivery of medically necessary products to patients. We anticipated the CDMO business to return to its pre-COVID growth trajectory as evidenced by our updated 2022 forecast of $115 million in revenue at the midpoint of our updated range. While lower than the performance we experienced during the pandemic, it is up from approximately 80 million in 2019. This and future growth will be driven by executing on the three initiatives I mentioned earlier. As Rich will detail in his remarks, our second quarter financial performance and updated full year 2022 guidance reflect the themes that I shared, namely the strength of our core medical countermeasure and commercial products businesses and the reality of the post-COVID environment for our CDMO offerings. I remain optimistic about Emergent's long-term success, driven by the continued strength of our core business, our commitment to improving quality and compliance, across the enterprise and the future potential of expanding product offerings, both through partnering and M&A, as well as our internal development pipeline. Looking ahead to the second half of 2022 and beyond, we expect to close the deal with Chimerix for Timbexa and begin fulfilling the contract with the U.S. government as planned. We've initiated a second phase three study to evaluate safety and immunogenicity of CHIC-V VLP vaccine candidate in adults 65 and above. This is in addition to the ongoing pivotal phase three clinical trial for individuals aged 12 through 64. We expect to have data from both trials in 2023. We will actively seek to qualify and operationalize our enhanced CDMO capabilities in support of internal products and new business from new and existing customers. And finally, we are continuously evaluating potential M&A and partnering opportunities that complement our core areas of focus and leverage our key capabilities. Before turning over to Rich, I want to formally welcome Sujata Dehal to the Emergent Board of Directors. She was appointed as our director effective July 15th We will benefit greatly from her decades of experience, particularly her expertise in healthcare compliance and legal and regulatory oversight. Importantly, I also want to thank the entire eMERGEd team for their relentless focus on our patients and customers in a rapidly changing world. And with that, I'll turn it over to Rich before taking your questions. Rich?

speaker
Bob

Thank you, Bob. Good afternoon, everyone, and thank you for joining the call. I'll start on slide nine with some summary thoughts. As you heard just now from Bob, while the business continues to make good progress towards our long-range strategic plan, our financial results for the second quarter were mixed. The core medical countermeasures, or MCM products, continue to perform well, are on track through the first half of the year, and remain a strong foundational component of the company. Our portfolio of medical countermeasure offerings is poised to expand with the anticipated closing of the acquisition of Pembexa, the oral antiviral smallpox treatment, and the collaboration with Ridgeback on Evanga, the monoclonal antibody treatment for Ebola. Of note, our updated guidance for 2022 does not yet include the impact of either of these products. For the commercial products, we also delivered solid outcomes in the quarter, driven principally by continued market demand for Narcan nasal spray in the public interest or PIP channel. Importantly, we expect the recent entrance of another generic product to increase competition in the PIP market starting in the second half of this year, and our updated full-year forecasts reflect the anticipated impact. As for CDMO, it is important to keep in mind that we are still re-baselining this business as we transition back to a pre-COVID growth trajectory in line with our strategic plan. The second quarter's results, as well as the updated 2022 full-year CDMO forecast, are informed by three primary factors. First, the wind-down of our relationship with Janssen. As disclosed in our AK filings in June, we believe the contract entitles us to significant payment upon termination. While we continue to pursue resolution of this matter, given the uncertain timing of any potential future payment, Our forecast does not assume any additional revenue, termination costs, or contingent liabilities stemming from Janssen in 2022. Second, the expectation of limited production capacity at Camden in the short term as we focus on systems upgrades that reinforce our ongoing commitment to quality and compliance. And third, a transition to a post-COVID environment as COVID-related demand wanes in the current phase of the pandemic. Taken together, our performance this quarter once again demonstrates the importance of revenue diversification and reinforces the overall strength and durability of our products and services business model. With that, let's turn to the numbers. As indicated on slides 10 and 11, highlights include total revenues of $243 million, a decrease over the prior year driven primarily by a significant reduction in COVID-related CDMO revenues that was offset by a solid increase in product sales revenue. And as expected, our key profitability measures declined versus the prior year with adjusted EBITDA of negative $29 million and adjusted net loss of $43 million. Other notable items in the quarter include anthrax vaccine sales of $96 million, higher than the prior year due to timing of deliveries of AV7909 to the U.S. government's strategic national stockpile. Nasal naloxone product sales of $102 million, slightly lower than the prior year and comprised of significant unit sales of branded Narcan to U.S. public interest and Canadian customers, as well as contributions from sales of the authorized generic product licensed to Sandoz. As expected, we continue to see lower branded Narcan sales in the U.S. commercial retail market as a result of the generic launch late in the fourth quarter of last year. Other product sales were $40 million, higher than the prior year driven primarily by deliveries to the U.S. government of VIGIV and deliveries of BAT to international customers. And to finish out the products discussion, note that there were zero ACAM revenues in the quarter. As has been the case for several years, we anticipate the next U.S. government option exercise and thus the majority of this year's ACAM revenue will be realized in the second half. Turning to our services segment, combined CDMO service and lease revenues were negative $2 million, significantly lower than the prior year driven by several factors. First, the reversal of $13 million of previously recognized revenues from the Janssen contract to align cumulative revenue recognized with cumulative cash collected. Next, in CDMO services revenues, the decline is largely due to lower combined revenues of $82 million from Janssen and AstraZeneca, reflecting reduced production activities at the Bayview facility for these two customers. The decrease also reflects limited capacity utilization at the Camden facility in the driven by both the annual maintenance shutdown and activities to strengthen quality and compliance. These factors were partially offset by an increase in contracted manufacturing activities at the Winnipeg facility. And finally, in CDMO lease revenues, the substantial decline was primarily due to the completion in November 2021 of the company's public-private partnership with BARDA in response to the COVID-19 pandemic. Turning to operating expenses, Cost of product sales in the quarter was $91 million, higher than the prior year due to the higher volume of product sales. Cost of CDMO was $79 million, significantly lower than the prior year due to reduced production across the CDMO network, partially offset by higher costs at the Winnipeg site, resulting from increased manufacturing activities during the period. R&D expense of $50 million. consistent with the prior year and reflecting our continued commitment to investments in pipeline programs intended to expand our product portfolio, and SG&A spend of $81 million, lower than the prior year due to reduced professional services and marketing costs, partially offset by higher compensation costs. Turning to additional financial information, let's move to slide 12 and review key CDMO performance metrics. As of June 30th, our total customer count was 70, decline of one on a sequential basis. And in the second quarter, we secured new business of $16 million, all from existing customers and substantially all for non-COVID work. Next, please turn to slide 13 for a review of segment performance during the quarter. As you know, on the first quarter call in April, we introduced segment reporting information by products and services using the two key metrics of revenue and adjusted gross margin to measure each segment's performance. In the product segment, revenues were $237 million, an increase over the prior year. An adjusted gross margin was $148 million, or 62%, both increases over the prior year, reflecting the impact of higher sales volume and product mix. As for the services segment, revenues were negative $2 million, a substantial decrease from the prior year for the reasons just discussed. An adjusted gross margin was negative $81 million, reflecting the decline in production activities across our CDMO network. Moving to slide 14, I'll touch on select balance sheet and cash flow highlights. We ended the second quarter in a strong liquidity position with $358 million in cash and available revolver capacity of just under $600 million. Our net debt position was $475 million, and net leverage remained modest at 1.3 times. Our operating cash flow was negative for the quarter and our investing and financing cash flows reflected our capital allocation priorities as follows. Second quarter capital expenditures were $32 million as we continued to invest in expanded capabilities and capacity to support our diversified products and services business lines. And in the second quarter, we repurchased approximately 700,000 shares at a cost of $23 million pursuant to the $250 million repurchase authorization approved by our Board of Directors in November of last year. Cumulatively, as of June 30, we have spent $188 million of this authorization to repurchase 4.4 million shares. Please turn to slides 15 and 16 for a review of our updated 2022 forecast and associated assumptions. As detailed in today's press release, we are resuming our guidance for the full year 2022 and have provided the following updated ranges. Total revenues of $1.15 billion to $1.25 billion. Anthrax vaccine sales of $280 billion to $300 million. Nasal naloxone product sales of $300 million to $340 million. ACAM2000 sales of $225 million to $250 million. Other product sales plus contract and grants revenues of $235 to $240 million. CDMO revenues of $105 million to $125 million, adjusted net income of negative $15 million to positive $10 million, adjusted EBITDA of $80 million to $121 million, and gross margin of 41 to 45 percent. This full-year 2022 forecast reflects the following key considerations. Medical countermeasure product revenues are consistent with our previous assumptions related to deliveries under existing U.S. government procurement contracts, including the assumed exercise of the ACAM 2000 option. Nasomaloxone revenues reflect our most current assessment of the competitive dynamics given our experience in the first half of the year, combined with the additional generic entrant in the second half of the year. CDMO revenues exclude any further contribution from Janssen. As discussed earlier, Our forecast also assumes certain short-term limitations on production capacity at Camden as we focus on quality and compliance upgrades, as well as the continued transition to non-COVID work across the network. Importantly, at the midpoint of $115 million, this updated level is a significant increase over 2019 CDMO revenue of $80 million, as we are benefiting from the operationalization of expanded capacity and capabilities at the Camden and Winnipeg sites. And as a reminder, the forecast does not include the impact of the pending acquisition of Tembexa or our collaboration with Ridgeback on Ibonga. Finally, we are forecasting total revenues for the third quarter of $230 million to $270 million. To conclude, please turn to slide 17 for some summary comments. Our performance in the second quarter once again highlights the strength and durability of our diversified products and services business. we continue to see significant opportunity in our core medical countermeasure and growing commercial product segment, addressing the preparedness and response needs of governments, patients, and other customers against a growing array of critical public health threats. We also see long-term potential for our CDMO offering, given our capacity and capabilities, coupled with the pace of innovation by our small to medium-sized biopharma customers in this post-COVID era. Additionally, our R&D programs continue to progress. We are investing to strengthen quality and compliance across our entire site network, and we will continue to prudently allocate our capital in a combination of M&A and partnering transactions, as well as focused capital investments while maintaining a strong financial position. We look forward to keeping you informed as we execute on these plans and deliver further proof points that demonstrate the long-term growth potential of our business. 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?

speaker
Operator

Certainly. Once again, if you have a question, please press star 1-1. Our first question, one moment for our first question. And our first question comes from the line of Brandon Foulkes from Cantor. Your question, please.

speaker
Brandon Foulkes

Hi, thank you for the guidance. Can you just elaborate a little bit on the price action you are seeing in the public interest market for Narcan? Just any color there in terms of sort of the magnitude of that headwind? And maybe just could you provide some color? Does this go state by state basis? And maybe if that price does come down in one state, how long does it take to sort of flow through to the other states? And then maybe just staying on Narcan, how do you think about potential implications for the proposed Tether settlement that was put out there, which included that portion of Narcan over 10 years? Thank you.

speaker
Jonathan

Yeah, good afternoon, Brandon, and thanks for joining the call. So a couple of comments. First, as we've commented on prior calls, what we expected to see in terms of pricing pressure in the market has materialized with the entrance of the two generic products, both at the retail level, which we expected, as well as now in the public interest market. I can't give you specifics on the magnitude of the pricing because it's still forming, but we are competing head-to-head with the generics for both market share as well as through pricing strategies. We were prepared for what we're going through right now. Having said that, we're quite encouraged by the fact that Narcan continues to perform exceptionally well in the public interest market, as we expected, given the name recognition and the years-long history that we have with supporting the supply chain needs of many, many customers in that very diverse state and local government market. So we're pleased with that, and quite frankly, kudos to the team for, again, sticking to our guns in terms of putting our emphasis on awareness as well as improving access to Narcan in those very important markets. I'm not sure I understand the second question. And maybe I'll go to... Sorry.

speaker
Brandon Foulkes

Go ahead. Okay. Just your thoughts on the potential implementation for that public interest market of that proposed settlement that Teva put out on its earnings of, I think it was $1.2 billion at WAC, fair enough, over 10 years. Just, you know, how do you think... I mean, in the past, you've talked about sort of logistic and ability to supply that market. So just any color and how we should think about if that settlement does actually come into effect.

speaker
Jonathan

Yeah, I understand. Thanks. So clearly we are kind of on top of monitoring, evaluating these market dynamics, including the potential settlement proposals that are being floated out there. I think it's a bit too early to say with any degree of certainty how that will all shake out. I think it's also important to note that for the first time that I can recall, this proposed settlement includes an option for the states to receive cash payment as opposed to product offerings by the company. So I think it's likely that a number of states will, in fact, opt out for cash so they can use the proceeds as they see fit in their states with their constituents. But we'll have to wait, Brian, and see how all that shakes out. But even with those headwinds, again, back to our expectations for the business in 2022, we're quite encouraged with the year-to-date performance, which gives us the conviction and the confidence to increase our guidance by almost $45 million in revenue for 2022.

speaker
Operator

Great. Thank you very much. Thank you. One moment for our next question. And our next question comes to the line of Jessica Faith from JP Morgan. Your question, please.

speaker
Jessica Faith

Hey, guys. Good afternoon. Thanks for taking my questions. On Camden, what was the FDA feedback you got? Was there any 483 issued? And then on your comments about CDMO rebaselining, Can you talk about what exactly you expect the new baseline to be and when you expect to hit the baseline? Is that like by the beginning of 23, middle of 23?

speaker
Jonathan

Yeah, thanks, Jess. So first on Camden, as I commented in my prepared remarks, we've had significant interaction with the FDA over the last year or so. In February of this year, they came for an inspection. There was a 43 issued. There were a handful of observations. We have not yet received the establishment inspection report. That's one of the outstanding components of feedback that we're waiting to hear from the FDA. While we await that additional feedback, as I said, we're being proactive in terms of taking additional measures in Camden and throughout all of our sites to significantly ramp up our quality and compliance profile, and whether that's through process improvements or training. Again, we're being pretty aggressive, but we'll await the additional feedback from the FDA, which we expect in the next probably 30 days. As it relates to CDMO, I think we see the growth opportunities for the business today much the same way we did when we generated our 2020 through 2024 strategic plan at the end of 2019, when the revenue for that business was about $80 million overall. And by that, I mean, we continue to think that the molecule to market service offering with both development services, drug product, as well as drug substance services is a really effective and unique way for us to pursue opportunities. We've talked a little bit about Bayview and the transition we're going there. We expect that work by unwinding or winding down the Janssen work to be done by the end of Q3, which kind of frees us up. to look for opportunities to more fully utilize that facility going forward, you know, later this year and into 2023. I think what's a little different about today versus a couple of years ago when we put the strategic plan together was the fact that we've made considerable investments throughout our CDMO network, both in terms of capital and in terms of new capacity and new capability, with new fill finish lines, with process improvements, but importantly, with our quality and compliance profile, with training, process improvements, and any number of initiatives that we're undertaking. So to get to your point about future growth, we expect the growth to be... a bit measured over the coming years. Again, it'll take us probably 12 to 18 months to fully kind of get the network back up and running effectively, leveraging the assets that we have. But we're going to be doing so with a considerable amount of tailwind, given the investments that we've made over the last couple of years.

speaker
Jessica Faith

Great. And then, forgive me if I missed this. Sorry, was there more?

speaker
Bob

Yeah, I was just going to add that, you know, you see that we've updated our CDMO guidance, you know, a range of 105 to 125. It certainly is a move towards that baselining effort. So, that is, we're already moving in that direction.

speaker
Jessica Faith

Okay. And then, forgive me if I missed this, but the ACAM guidance bump, can you explain what that's related to?

speaker
Bob

Yeah, so that's both a combination of assumed deliveries under the typical option exercise as we've had in the past couple years, and then we've also had some international sales on top of that.

speaker
Jessica Faith

Okay, thank you.

speaker
Operator

Thank you. One moment for our next question. And our next question comes from the line of Boris Peek from Cowan. Your question, please.

speaker
Boris Peek

Hi, thanks for taking my question. This is Nick on for Boris. So I just have a quick question about Chimerics and Pembexa. So previously, they write pretty much right after you guys announced this, this acquisition of Pembexa, they said that the bar contract was likely to take place within the next couple weeks or months. And now it's pushed back. And I just wanted to know if you guys had any reasoning behind this or any information as to why it's been pushed back, especially with monkeypox and now being declared a public health emergency. You can kind of think that it may be pushed forward, but it seems to be just pushed back a little bit more. Thanks.

speaker
Jonathan

Yeah, thanks, Nick, for the question. Thanks for joining the call. So a couple of comments. As I commented on my prepared remarks, the HSR process and the waiting period for this expired last Friday. So now that I think gives BARDA and Commerics kind of the green light to finalize the BARDA procurement agreement, which then gives us the clear path to closing the transaction and moving forward. I wouldn't read anything into the perhaps perceived delay in getting the contract awarded. Obviously, BARDA is looking at this very carefully. And they are aware that, you know, our interest in acquiring the product from Chimeric. So I think, again, there's momentum to get this done and we're anxious to get it done as well.

speaker
Boris Peek

Great. Thank you. And then just quickly on the, you mentioned just a second ago that you had some international sales for ACAM 2000. Is that just like one-time sales or are those more so contracts? I don't think I've seen any press releases on that recently.

speaker
Jonathan

Yeah, Nick, so we've had a number of ongoing communications with allied governments and public health threat organizations regarding their interest in our entire portfolio of medical countermeasures. As Rich indicated, we are forecasting a bit of an uptick with respect to ACAM, but we've also seen interest in any number of our other products in the portfolio. So this is part of the ongoing process. It's what we've been talking about for a number of years in terms of allied government interest in the entire portfolio. So nothing new here, just obviously in today's environment, there's a heightened sense of understanding and appreciation for having ready access to these critically needed countermeasures.

speaker
Boris Peek

Great, thank you very much.

speaker
Operator

Thank you. And as a reminder, ladies and gentlemen, if you have a question, please press star 1-1 on your telephone to ask a question. One moment for our next question. And our next question comes from the line of Chris Sakai from Singular Research. Your question, please.

speaker
Chris Sakai

Hi, yes, I'm in for Lisa Springer here. Can you provide some color on the generic share you are seeing for the public interest in the nasal spray segment? Is it growing?

speaker
Jonathan

Yeah, Chris, thanks for the question, and thanks for joining the call. So, clearly, as we expected, the generic products are and have claimed the majority of the retail market, and now with the introduction of the second generic product recently, they're making some inroads into the public interest market, but we remain quite optimistic about our ability to hold our fair share of that market. I think our team is doing an extraordinary job of interfacing with literally the thousands of customers in that public interest market, and our commitment in our investments in establishing relationships with those customers, taking care of their supply chain needs, meeting their requirements, is paying benefits. And there's a significant value to the brand name and brand recognition of Narcan and the reputation we have for being reliable supply chain providers for that countermeasure. So we're quite bullish on our ability to hold market share in that public interest market.

speaker
Chris Sakai

Okay, thanks for that. And looks like there's some updated guidance here on the nasal products.

speaker
Jonathan

We're quite bullish on our ability to hold market share in that public interest market.

speaker
Chris Sakai

Okay, thanks for that. And looks like there's some updated guidance here on the nasal products. You know, how should we think about this the cadence of these sales?

speaker
Jonathan

Yeah, so I think you're referring to our updated guidance for Narcan Naloxone products. We've updated the range from 240 to 310 to 300 to 340. So midpoint to midpoint, it's about a $45 million in revenue increase. So I think, again, that reflects a couple of dynamics most importantly, the continued emphasis and demand at the state and federal level by any number of customers for Narcan. In terms of the cadence over the remaining year, we don't go into details about what amount of that is in Q3 or Q4. But as Rich indicated, we've given the total revenue projections for Q3, and that's as much detail as we're kind of prepared to provide right now.

speaker
Chris Sakai

Okay, thanks for that.

speaker
Operator

Thank you, Chris. This does conclude the question and answer session of today's program. I'd like to hand the program back to Bob Burrows for any further remarks.

speaker
Bob Burrows

Thank you, Jonathan. And with that, ladies and gentlemen, we now conclude the call, and 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's website. Once again, thank you, and we look forward to seeing you again.

speaker
Operator

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day. The conference will begin shortly.

speaker
Jessica Faith

To raise your hand during Q&A, you can dial star 1 1.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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