Emergent BioSolutions Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Emergent BioSolutions 3rd Quarter 2021 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 on your telephone keypad. If you require any further assistance, please press star 0. I would now like to hand the conference over to the company. Please proceed.

Thank you, Cherry, and good afternoon, everyone. This is Bob Burrows, Investor Relations Officer for the company. Thank you for joining us today as we discuss the operational and financial results for the third quarter 2021. As is customary, today's call is open to all participants, and the call is being recorded and is copyrighted by Merchant 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 the slides three and four, during today's call, we may make projections and other forward-looking statements related to our business, future events, or 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 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 followed 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 3Q21, as well as the forecast for full year 21. 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 November 4, 2021. Since then, Emergent may have made announcements related to topics discussed during today's call. And with that introduction, I would now like to turn the call over to Bob, whose comments begin with slide six.

Bob? Thank you, Bob, and good afternoon, everyone. Thanks for joining the call. Today I'll provide an update on the progress that we've made at our Bayview site and then talk a little bit about our recent accomplishments and milestones and further talk about the business enhancements we've implemented to better focus on our customers. I'll also discuss our revised full-year guidance and our decision to end our involvement in the Centers for Innovation and in Advanced Development and Manufacturing, or CIADM, program with the U.S. government. My comments are summarized across slides seven and eight in the deck accompanying the call. So let's get started. As you've seen this year, our emergent team in our business has shown their strength and resilience as we've made substantial progress in the quarter. Some of the recent highlights include the following. First, we've made significant progress in Bayview, resuming operations and production for Johnson & Johnson at the end of July, and more recently, completing all remaining work on behalf of AstraZeneca. As of the end of the quarter, we've contributed over 100 million dose equivalents of COVID-19 vaccine for global distribution. Importantly, we look forward to continuing to support J&J's ongoing vaccine production in the months ahead while continuing to support their regulatory path for their vaccine. Next, we secured key ongoing commitments from the U.S. government on two core medical countermeasure products. First, we received a contract modification exercising and funding the second of nine annual options to supply ACAM-2000 to the strategic national stockpile valued at approximately $182 million. Secondly, we received the contract modification, exercising and funding the procurement of additional doses of AB 799 for the SNS valued at approximately 399 million over the next 18 months. Also, our Narcan nasal spray team continues to perform well above expectations in the midst of a worsening opioid crisis, helping ensure this critical product gets in the hands of the patients and caregivers who need it. We also launched our pivotal phase three trial for our chikungunya vaccine, CHIKVVLP, a key milestone for us because it's the first phase three drug development program that Emergent has funded on its own. More importantly, it underscores our commitment to progressing our pipeline programs in pursuit of critical public health threats and expanding our tribal health vaccines franchise. And finally, we continue to grow our CDMO operations, securing a new multi-year contract to produce Providence Therapeutics mRNA COVID-19 vaccine candidate at our site in Winnipeg. As these highlights demonstrate, our core strategy and diversified business model remains strong. In addition, today we're announcing that the Department of Health and Human Services and Emergent have mutually agreed to end our partnership in the CIADM program. The agreement will close out all open obligations and task orders issued under CIADM base contract, including the task order related to COVID-19 response. We're proud of the work all of our employees have done over the last nine years to honor our CIADM commitments. And you will recall that the program was initiated in 2012 in recognition of the shortage of domestic manufacturing capability needed to respond to an unforeseen widespread public health threat following the H1N1 influenza pandemic. While an innovative idea, execution of the CIADM program and the necessary operational investments by all administrations fell short of what was needed to maintain capability in case of an emergency. In fact, when the COVID pandemic struck, Emergent was just one of two original partners remaining in the program. Despite the issues, we responded swiftly, engaging several of our facilities to meet the government's needs and made incredible progress in a timeframe never before attempted under very challenging conditions. Our COVID-19 work with BARDA under the CIADM program included a number of activities. These included a reservation of capacity at our Bayview, Camden, and Rockville sites, a direct capital investment by the government and additional fill finish capacity at our Camden and Rockville sites, bulk drug substance manufacturing for AstraZeneca in the reserve space at Bayview. And finally, drug product manufacturing for various COVID-19 therapeutic candidates in the reserve space in Camden. As a reminder, the COVID-19 work under the CIADM program was always expected to end this year. And importantly, our decision does not affect our work with Johnson and Johnson, as it was never part of our CIADM contracting. We will continue to produce their COVID-19 vaccine drug substance at our Bayview facility. And as I mentioned at the top of the call, we're extremely proud that our collaboration with J&J, and in addition to AstraZeneca, has contributed over 100 million dose equivalents of COVID-19 vaccine for global distribution. So while we conclude our involvement in the CIADM program and bring to closure this important chapter in our business, it needs to be said that the work we accomplished under the program and related task order contracts with the U.S. government served a critically important purpose, one that our entire organization is immensely proud of. Despite the setbacks we had earlier in the year, the team has been committed to our mission of protecting and enhancing life, and steadfast in learning from our past to be even better. I'm proud of the team's resilience and the positive impact on millions of lives across the globe and importantly, we're not done yet. As we look forward, we're encouraged and optimistic about the opportunities we see ahead across our entire business. Let me now pivot to recent business changes we've implemented in support of our strategy. During the quarter, we've shifted our operating structure to now have three business lines, each focused on distinct customer or market types. They are the newly created government or medical countermeasure business, the commercial business, as well as the services or CDMO business. which remains essentially unchanged. To be clear, all three of these report to our Chief Operating Officer, Adam Havey. The government or MCM business will be led by Paul Williams, who was previously running the vaccines business unit. This new structure will better serve our customers by sharing their breadth and depth of experience as one team and reduces the complexity with multiple touch points going into the government on different business units. The commercial business will be led by Doug White, who previously ran the devices business unit. He will not drive our core commercial capabilities and seek new investment opportunities. Doug's portfolio includes Narcan nasal spray, travel vaccines, and other similar customer-facing products. This organizational change provides an opportunity to put the strategic and operational pieces of this business under one umbrella that were previously across multiple business units, positioning us to expand into new markets and efficiently integrate newly acquired products in the future. The services or CDMO business, the head of which we're continuing to actively recruit for, will continue to service our pharma and biotech innovator customers, providing development, drug substance, and drug product manufacturing services that capitalize on our core skills and capabilities. As for our R&D programs, we established a centralized and cross-functional product development committee that will govern the R&D portfolio. We're also creating a science and innovation team led by Dr. Laura Sayward, who previously ran the therapeutics business unit. Overall, this new structure positions us to execute effectively on our strategic plan and deliver long-term success, strengthening our foundation and providing new opportunities for growth. So getting back to the operational highlights, as I mentioned, we resumed production of J&J's COVID-19 vaccine at our baby facility in late July, following the implementation of rigorous and comprehensive quality enhancements and the FDA's permission to restart. Over the last five months, we've invested millions of dollars to overhaul cleaning procedures upgrade our facilities, implement additional quality control and oversight practices, and make significant improvements to the processes for batch record keeping, personnel training, data integrity, and lab testing. Emergent teams, along with support from our J&J colleagues, oversee all operations and materials transfer. We took the added step to bring in a recognized independent consultancy who is expert in quality control and who are now reviewing and performing certifications prior to release of any batches. We continue to work closely with the FDA and J&J toward increasing our production level consistent with these new procedures. Finally, I want to commend our team who's around the work efforts over the last 18 months have accelerated the transformation of our Bayview facility from a clinical stage facility to one that is poised to support much larger scale production. Now moving to our core government or medical countermeasures business. Our work helping the US government protect Americans against smallpox, anthrax, and other category A biologic agents remains a top priority for the company. Recall that we previously announced the U.S. government exercised and funded the next term extension for ACAM 2000 under our 10-year contract, and we also secured the next option exercise for our smallpox therapeutic VIG-IV. We recently filed that up with the U.S. government exercising the final option under the existing contract to supply doses of our next generation anthrax vaccine candidate, AB799, to the Strategic National Stockpile valued at approximately $399 million over the next 18 months. As a reminder, the current contract for AB799 facilitates procurement by the SNS while we seek full FDA approval. And to that end, I'm pleased to announce two important updates today on the ongoing regulatory path for AB 7909. First, the FDA has agreed to our request for a rolling review of the AB 7909 BLA The rolling review allows us to submit sections of the application to the FDA as they're completed, rather than waiting until the entire BLA package is compiled. We anticipate initiating the BLA submission in mid-December. Based on this timing, we anticipate BLA approval by the FDA in late 2022 or early 2023. Second, the FDA has granted orphan drug designation for AB 7909. This designation provides development incentives, including a waiver of the DOA filing fee, as well as potential seven year marketing exclusivity upon regulatory approval. On the R&D front, we recently initiated our pivotal phase three safety and immunogenicity study for our single dose chikungunya vaccine candidate. Check the DLP is the only virus like particle based vaccine candidate currently in development for active immunization against chicken guinea disease. The study expects to enroll 3150 participants in 50 US sites in the coming months. I'd like to congratulate the teams across our organization who made this significant milestone possible and who are advancing the development pipeline that will help fuel the long-term growth of the company. We look forward to updating you on this program as we make progress. Finally, with the potential launch of a few other phase one studies anticipated over the next year, as well as continued progress across our autoinjector platform programs focused on chemical threats, I remain encouraged by the contribution of our R&D programs and the effect they could have on our growth in the coming years. Moving next to our CDMO business, I want to highlight that we continue to see growth in this area, both related to the pandemic and beyond. We continue to receive interest from both existing clients and new prospects from small, mid, and large-sized companies, as well as governments and other organizations. Importantly, we're winning new business across all three service pillars, of development services, drug substance, and drug product, including drug packaging. For example, during the quarter, we signed a new five-year agreement with Providence Therapeutics to support its mRNA vaccine development out of our Gaithersburg and Winnipeg facilities. Building off an existing agreement, this new baseline agreement is valued at $90 million and uses portions of all three of our integrated service capabilities demonstrating the value of our integrated molecule to market model for customers. We will continue to cultivate growth, expansion, and maturation of this core business. With respect to Narcan nasal spray, our focus on the public health threat posed by the opioid epidemic is as strong as ever. Our Narcan team has worked tirelessly to ensure that Narcan nasal spray is available and affordable as overdoses continue to devastate families and communities nationwide. We remain committed to combating this crisis, not only through our work on Narcan, but also through outreach efforts and public campaigns to elevate awareness of the dangers of opioids. On the ongoing patent infringement litigation front, recall that the U.S. Circuit Court of Appeals held final oral arguments on August the 2nd of this year. While timing is up to the appellate court, we continue to believe a decision could come by the end of this year. Importantly, in the event of a generic entry, we're prepared to launch an authorized generic product in partnership with a large generics company and are confident in our ability to maintain significant market share. Longer term, we see Narcan and more broadly, our opioid related portfolio, a core component of our portfolio solutions impacting public health. Finally, let me update two important corporate updates. First, I'm pleased to announce that we intend to publish our inaugural ESG or sustainability report later this month. The report will provide insight into our environmental, social, and governance practices. These include product quality and patient safety standards, our human capital and employee-focused programs, our existing charitable and volunteer programs, our work to safeguard the environment and health of our communities and employees, as well as our corporate governance and business ethics principles and practices. I also wanted to note that on a personnel front, Mary Oates, previously our head of global quality, has decided to pursue a new career opportunity and has left Emergent. We're conducting an external search for a new head of global quality. In the meantime, I'm confident that our team of talented, dedicated professionals will continue the important quality advancements made in the last several months. To conclude, our third quarter operational results demonstrate that our business remains resilient and poised for growth in line with our strategy. We continue on our path of both organic opportunities and potential M&A informed by prudent capital deployment, all aimed at generating enhanced shareholder value. With that, I'll turn the call over to Rich, who'll take us through the detailed results for the quarter.

Rich? Thank you, Bob. Good afternoon, everyone, and thank you for joining the call. I'll start on slide 10 and open my remarks with some summary thoughts to put today's earnings report into context. As you just heard from Bob, solid execution in the third quarter continues to illustrate the strength and durability of our differentiated business. Our medical countermeasures platform was further reinforced by the ACAM 2000 option exercise in July and the AB7909 contract modification on September 3rd. We have restarted operations at Bayview and are helping J&J deliver on commitments related to their COVID-19 vaccine candidate. The Narcan nasal spray franchise is gaining momentum as we support the battle against the continuing public health crisis in opioids. We are making steady progress building our CDMO business as evidenced by recent contract awards. And we are advancing our R&D programs most notably with the recent launch of the chikungunya phase three trial. Having said that, there are clearly several topics that merit further explanation starting with the primary drivers of our revised 2021 financial guidance as laid out on slide 11. The biggest influence relates to our mutual agreement with the U.S. government to terminate the CIAVM contract and associated task orders. As we disclosed in an 8 file this afternoon, as part of this agreement to close out the arrangement, the value of the BARDA task order was reduced by $180 million. This change will be partially offset by the recognition of $60 million in deferred revenue and other final payments related to the CIADM base agreement. You'll also note that given continued strong momentum in Narcan nasal spray, we increased the full year forecast range of that product by $95 million. After taking into account various other puts and takes, we have tightened the range of our total revenues, which lowered the midpoint by $50 million. We also disclosed in today's press release that as of September 30th, we reversed $86 million of revenue and removed accounts receivable balances related to uncollected amounts under the BARDA task order. During the third quarter, following a review of our revenue recognition policy, we determined that it was appropriate to reclassify certain suite reservation fees from stand-ready obligations to leases, and therefore to apply lease accounting guidance. You will note that our income statement now has separate line items for CDMO services and CDMO leases. This change should also allow you to better understand the underlying fundamentals of our CDMO service-related revenue. Under the lease accounting guidance, based on uncertainty regarding collectability of the full contracted amount, we converted to a cash basis of accounting for the BARDA task order. Accordingly, in the third quarter, we adjusted our revenue to align with the $315 million of cumulative cash collected under the BARDA task order from May 2020 through September 2021. Looking ahead to the fourth quarter, pursuant to the termination of the CIADM agreement, we expect to recognize $215 million of revenue comprised of $155 million of task order closeout payments and the $60 million of deferred revenue and other I just discussed. Termination of the CIADM agreement also results in asset write-downs of approximately $38 million So we expect the net addition to pre-tax income in the fourth quarter related to this event to be approximately $177 million. Second, CDMO metrics. During the quarter, our new business wins were $118 million, a very strong performance for the organization, primarily reflecting the impact of the Providence Therapeutics contract for COVID-related work. As for backlog, the sequential change reflects the impact of the termination of the BARDA task order. Regarding the opportunity funnel, the period-to-period decrease reflects both the conversion of opportunities into secured business as well as two large contract opportunities that we did not win. One is a company that decided to take the work in-house and the other is one that decided to defer the work to a future time. That said, we continue to identify new leads and secure new business, and this period-to-period fluctuation is not surprising as we pursue opportunities. Lastly, gross margins and profitability. As we have previously discussed, our gross margins are primarily driven by revenue mix across several dimensions. Product sales, proportion of products versus services, and the types of services delivered. the adjusted gross margins on our products continue to remain stable and consistent with historical patterns. On the CDMO services side, however, we are currently seeing several trends which are applying pressure to margins. These include lower capacity utilization for drug substance production at Bayview while it is solely dedicated to J&J's COVID-19 vaccine candidate, the additional investments we are making at Bayview in support of our quality enhancement plan, and higher raw material costs than originally anticipated. While these factors are currently producing CDMO gross margins below our expectations, over time we anticipate that CDMO profitability will improve as we continue to grow our CDMO revenue base, increase network utilization, drive a higher mix of drug substance manufacturing, realize scale efficiencies, and improve productivity. To facilitate investors' understanding of these trends, please note that today's press release includes separate calculations of product gross margin and CDMO gross margin. With that, let's turn to the third quarter numbers. As indicated on slide 12, highlights include total revenues of $329 million below the prior year period and our guidance, principally due to the $86 million reversal of revenue for the BARDA task order I mentioned earlier, an adjusted EBITDA of negative $3 million, an adjusted net loss of $19 million, both significantly below the prior year period and due to a variety of factors, which we will discuss in a moment. Other key items in the quarter include Narcan nasal spray sales for $133 million, an increase over the prior year reflecting a clear continuation of this franchise's robust performance and driven by continued strong demand for this critical drug-device combination product for opioid overdose reversal across both the retail and public interest channels in the United States, as well as increased Canadian sales. ACAM 2000 sales were $81 million, higher than the prior year due to timing of deliveries following our announcement in July of the U.S. government's exercise of the second option under the existing 10-year procurement contract. As we've stated previously, we expect to complete all related deliveries under this option exercise by the end of 2021. Anthrax vaccine sales were $16 million lower than the prior year due to timing of deliveries as the modification to the BARDA contract for 87909 was not made until the last day of the quarter. Other product sales were $41 million consistent with the prior year and CDMO revenues came in at $42 million lower than the prior year period due primarily to our move to cash basis revenue accounting for the BARDA task order and partially offset by $38 million in out-of-period adjustments related to our change in CDMO services revenue recognition policy, which will be detailed in our 10 filing. Looking beyond revenue, we are now breaking out cost of goods sold between product and CDMO services. Product cost of goods sold in the quarter were $103 million a $17 million decrease from the prior year, largely due to one-time charges in the prior year offset by increases in the current year due to higher product sales. CDMO cost of goods sold were $114 million, an $86 million increase over the prior year, reflecting the impact of out-of-period adjustments of $37 million, as well as incremental costs at our Bayview facility, as mentioned previously. Gross R&D expense of $50 million, lower than the prior year, primarily reflecting a non-recurring $29 million impairment charge in the prior year. Net R&D expense of $33 million, or 10% of adjusted revenue, in line with the prior year. SG&A spend of $82 million, or 25% of total revenues, an increase over the prior year reflecting growth in headcount and professional services, and gross margin was 30% in the quarter. As I mentioned earlier, we are now providing two additional gross margin metrics. Adjusted product gross margin was 62% of product sales consistent with the prior period. And adjusted CDMO services gross margin was 10%, lower than the prior period, primarily reflecting the impact of increased operating costs at our Bayview facility and the implementation of our quality enhancement plan. Turning to slide 13, we will now review our key CDMO metrics. In the third quarter, we secured new business of $118 million, reflecting robust demand for our services. As of September 30th, the rolling backlog was just over $1 billion, a 9% decline from the second quarter, reflecting the impact of the bar to task order termination. You will find a detailed roll-forward table related to backlog on page 5 of today's earnings press release. And lastly, as of September 30th, the opportunity funnel was $284 million, down from $672 million at June 30th, As I said before, primarily reflecting a significant new business win in the current quarter, as well as the loss of two large opportunities. On slide 14, you can see the sequential trends in these metrics over the last five reporting periods. We look forward to making further progress in this important part of our business as we move forward from here. Moving on to slide 15, I'll touch on select balance sheet and cash flow highlights. We ended the third quarter in a strong liquidity position with $404 million in cash, an undrawn revolver capacity of just under $600 million. Our net debt position was $454 million, and our ratio of net debt to trailing 12-month adjusted EBITDA was one times. Our year-to-date operating cash flow was negative $8 million, primarily reflecting timing of cash collections and increases in inventory balances. Additionally, we reported cumulative year-to-date capital expenditures of $178 million. Please turn to slide 16 and 17 for a review of our 2021 forecast and associated key considerations. As detailed in today's press release, we are revising our 2021 outlook and our new ranges are as follows. Total revenue of $1.7 billion to $1.8 billion. Narcan nasal spray sales of $400 million to $420 million. Anthrax vaccine sales of $250 million to $260 million. ACAM 2000 sales of $200 million to $220 million. And for the CDMO business, we now anticipate a range of $600 million to $650 million. Our profitability guidance includes adjusted EBITDA of $500 million to $550 million and adjusted net income of $315 million to $350 million. Importantly, our 2021 revised outlook takes into account a number of key considerations which are listed in our earnings press release, and many of which are unchanged from our last update in July. These include no Raxibacumab revenue this year, the Naloxone market remains competitive with at least one new entrant this year, which we actually saw with a branded competitor coming on market in Q3, no generic entrant prior to the resolution of our patent litigation case, and the continued manufacturing of J&J's COVID-19 vaccine at Bayview. The considerations that have been revised are as follows. We've incorporated the financial implications of our mutual agreement to terminate the CIADM agreement and related task orders, including the expected payment in Q4 of the relevant agreed-upon amounts. And the expected range of adjusted gross margin is now 54% to 56%, taking into account both year-to-day performance and anticipated performance in the fourth quarter. On a different note, given the changes we have seen in our business during the pandemic, we've received a number of questions about what to expect from the business going forward. As you know, our custom has been to provide a first look at annual guidance at the beginning of each calendar year once our budgeting process is complete. We expect to maintain that practice for 2022, but I would like to offer a few thoughts on directional trends so you can better understand the shape of the underlying business. In terms of top line revenue, We haven't finished our budgeting process for 2022, but the current analyst consensus for total 2022 revenue directionally seems to be in line with our thinking. More specifically, we anticipate that our medical countermeasures business will remain steady with high visibility provided by the long-term contracts we currently have in place. The opioid crisis has been worse than we anticipated when we acquired the program, and as a result, Narcan nasal spray revenue has continued to exceed expectations. Of course, the question on everyone's mind is what will happen if a generic competitor enters the market. More than half of our market is in the public interest space, and so not necessarily subject to the usual automatic switch for AV-rated products. And for the remaining product markets, as Bob said, we are prepared to launch an authorized generic in partnership with a large generics company. All in all, we are confident that it will continue to be a meaningful contributor to both our top and bottom line going forward. On the travel health front, we are monitoring and calibrating our expenses to international travel conditions and do not anticipate meaningful revenue from our travel vaccines next year, although we are expecting upticks in travel following that. For CDMO, we expect we will continue to support J&J out of our Bayview site and build on the opportunities we see to serve customers from several of our other revenue generating sites. In terms of profitability, we are making investments in our manufacturing and quality systems that are putting pressure on our CDMO gross margins, but we expect these will continue to gradually improve over time. And we are taking a disciplined approach to managing our SG&A expenses as we prepare for a return to stronger top-line growth in 2023 and 2024. With respect to R&D, we continue to invest in long-term value drivers as well as programs with non-dilutive funding, but we are balancing those investments with some anticipated portfolio rationalization. As a result, we currently anticipate that these trends may constrain adjusted EBITDA margins to a level that is at or below the ranges we saw in 2018 and 2019. We will refine these views and expect to provide more definitive information early in the new year. To conclude, please turn to slide 18 for some summary comments. In the third quarter of 2021, we continue to deliver solid performance in certain key aspects of our business, anthrax vaccines, ACAM 2000, and the rest of the core medical countermeasure products, the Narcan nasal spray franchise, as well as the new business wins in CDMO services. We also experienced continued forward progress at scaling up the production capabilities at the Bayview site in support of J&J. And we realized an important pipeline milestone with the CHIC vaccine phase three trial launch last month. While our guidance for this year has been revised a bit to reflect the termination of the CIADM agreement, as well as current profitability trends in our CDMO business, bringing the CIADM agreement to a conclusion was a clarifying step forward for the company. Finally, our conviction in the long-term growth potential of our business is as strong as it has ever been. 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?

Ladies and gentlemen, if you have a question at this time, please press star, then the number one on your telephone keypad. Again, everyone, if you have questions, please press star one on your telephone keypad. Your first question comes in the line of Brandon Fox from Cantor Fitzgerald. Your line is now open. Hi.

Thanks for taking my questions. Maybe firstly, just on the CIA DM contract, can you maybe just elaborate in terms of your relationship with HHS, you know, and maybe the individuals responsible for that contract versus any impact on your relationship with the strategic national stockpile? Um, and just any clarification on the statement that, uh, you know, there's a reversal of the revenue base to lack of cash collection. Did they stop paying you before the mutual termination of that agreement? And then secondly, maybe just a knock and, um, Do you expect a generic entry or an AG to expand the market at a faster rate than it is currently expanding, or is price not really a limitation in that market at this stage? Thank you.

Thanks, Brandon. So I'll take the first part of the first question. I think we all recognize that the CIADM, as it was contemplated back in 2012, was a good idea at the time, but unfortunately it didn't work out as it was anticipated. I think secondly, likewise, that the task order for COVID-19 work that we've been doing was also a good idea. And to be clear, the government and the public in general has benefited significantly from the activities that were conducted under that task order. I think the government's decision to remove the AstraZeneca product from Bayview and to not direct additional work to Bayview to take its place made it pretty clear that they no longer needed that reserved space. And while we were legally entitled to receive the full payment under the task order and the contractual obligations, we made the business decision after discussions with the government to the best way forward was to end the task order in the CIADM relationship. Part of your question was really related to the relationships between kind of the CIADM and the SNS. And to be clear, CIADM is governed and overseen by BARDA under HHS. The Strategic National Stockpile is really under the ASPR, the Assistant Secretary for Preparedness and Response. So it's a sister organization, but not directly under BARDA. Maybe I'll turn to Rich in terms of the accounting and the cash question. Brandon.

Yeah, so Brandon, to answer your question, yes, the government had been behind on payments related to the task order. You know, as you can appreciate, every quarter we do an assessment of our accounts receivable and based on our assessment at the end of the second quarter, we had believed that it was probable that we were going to collect those amounts. As we came to September 30th, based on Where we were at that point in time, we determined that it was no longer probable that we were going to collect 100% of the contracted amount. And as a result, that triggered a need for us to convert to cash basis of accounting for that under the lease accounting guidance. And so that is why when we compared the amount of revenue that we had accrued up to that point with the amount of cash that we had actually collected, there was a difference of $86 million, which we reversed in the third quarter.

Thanks, Rich. Brandon, I'll address your second question, which is, I think if I understand it correctly, you were asking whether or not a generic entrant and an authorized generic entrant into the lock zone space would have any material impact on the overall market size. I think it's a little too early to guess what that impact would look like. To be clear, I think that the nasal-delivered naloxone market, as you can probably attest to, is still developing. Our focus since acquiring the asset three years ago has been really to increase awareness, to educate, and to make sure that product is available to the millions of patients and customers who need ready access to it. So I don't anticipate much of an impact, but we'll have to wait and see.

Great. Thank you, too, both. I appreciate the additional color. Thank you.

Thanks, Brian.

Your next question comes to the line of Jessica from JP Morgan. Your line is now open.

Hey, guys. Good evening. Thanks for taking my questions. So appreciate you kind of bridging us from the and kind of through the decline in the opportunity funnel. I'm curious approximately how many potential clients are represented in the current opportunity funnel now, and what's the average kind of contract size in there? And second, over what timeframe do you typically get clarity on whether a contract is moving forward or not? So I guess how long does pitched business kind of sit in the funnel before you get clarity?

Yeah, just thanks. Great, great question. So we haven't broken out the number or the average potential deal size in the opportunity funnel. I think as Rich indicated, the two opportunities that he called out, one was kind of taken off the table because the party decided to take it internal versus putting it out for bid and going to an external CDMO relationship. And I guess the other was deferred, so that may come back, but no assurance that it will, Jess. I'd be guessing, quite frankly, at the duration of how long things sit in the funnel. I think we have pretty good clarity that once there is a request for a proposal that is given to us and that we respond to. I would think within probably three to six months we know or have a pretty good idea whether it's going to be acted upon or actionable or not. So that would be my estimate, Jess.

Okay, great. And maybe just two more. One, following up on the last question on Narcan, maybe a bigger picture. When you talk about that representing a core part of the long-term portfolio, Can you elaborate on what that looks like, how you envision it remaining a core part, you know, longer term? And then lastly, and I think you kind of addressed this, but I was curious if there's any positive CDMO lease revenue in the third quarter that's being offset by the BARDA negative revenue item. And I think based on the 86 you just cited before, maybe it's like 15. Is that right?

Yeah, just to knock that one off quickly, yes, there was $15 million of positive lease revenue that was offset by the negative 86 related to BARDA. Okay.

Yeah, and just on your first question regarding NARCAN and... I guess our view that it's core, I'll say a couple things. I mean clearly it's outperforming our expectations today and clearly the expectations that we had when we bought the asset a number of years ago as Rich articulated in 400 million in revenue projected for this year, the range of 400 to 420 is clearly a positive impact Even in a generic setting where there is a generic entrant and our authorized generic product competing for space, just to be clear, as we've talked about on prior calls, we see that kind of competitive dynamic looking different in the retail market. than in the public interest market for a couple of important reasons. Most notably, in the public interest market, as you know, the product is already discounted at a 40% discount. So the attractiveness economics is not the typical kind of branded versus generic, fight it out for market share in that retail space. So even with a authorized generic and generic competing in the retail space, and some pressure and some competition in the public interest market. I mean, for us, it's still a sizable asset going forward. And that, you know, is notwithstanding the fact that we continue to look for additional assets and additional lifecycle management opportunities for Narcan nasal spray, including you know, the work that we've done to date regarding dating and the temperature range for the product, as well as the by-dose product. So we think it's an attractive area, and importantly, it really is on point with our strategy of protecting and enhancing life.

Thank you.

Thanks, Jeff.

Your next question comes to the line of Ki Nake from Chardon. Your line is now open.

Yes, thank you. A couple of questions. Just follow up on the last one with respect to having an authorized generic. How much price pressure do you think that introduces in the retail market?

Yeah, I think thanks for joining the call and thanks for the question. I think as with any branded versus generic competition, it's going to be much like it is anywhere else. So there's going to be significant pressure on price. When a generic comes in, we're clearly gonna lose some market share. We'll gain some back with our authorized generic. That dynamic, again, is gonna be, we think, different in the public interest market for the reasons they articulated. Not that it's gonna be, not be able to be penetrated by a generic, but we think that competitive dynamic is much different in the public interest market versus the retail market.

Okay, and just going back also to an earlier question about your relationships, you know, how would you characterize the strength of your relationship with people over at ASPR?

Yeah, I mean, Kay, I think it's very strong. You can look to a number of proof points, including the two significant procurement contracts that were exercised and funded recently along with the VIGIV contract so I mean as we talked about you know earlier this year we had a couple of very important contract modifications and extensions to kind of get across the finish line and I think that the team and I are very proud of the fact that we've kind of worked through this I know that a lot of folks on the outside looking at us were concerned that The challenges that we've had with COVID-19 response, we're going to somehow impact that core of the business. That's clearly not the case, and we move forward.

Okay, final question. For your hyperimmunes for COVID, I know COVID-HIG, you know, recently went into a phase three. Are you still doing development work for COVID-EIG?

Not really, Kay. We've kind of put that on the back burner in order to prioritize our effort on the COVID-HIG side. And, you know, it's potentially at a stage where we could reinvigorate, but right now the focus is on COVID-HIG with NIAID.

Okay, thanks.

Your next question comes from the line of Lisa Springer from Singular Research, your line is now open.

Hi, Robert Maulby in for Lisa. Thank you for taking my questions. Regarding the contract, CIA DM contract and the amount the government, how common is it for, in your experience, for the government to get behind? And what's the rationale and not collecting the balance owed?

Yeah, Robert, thanks. It's been a while since we talked. Thanks for joining the call. I'm going to let Rich respond to the collectability or the responsiveness of payment by the government. But as you follow this for many, many years, you know that the government has always paid within a very short period of time. I think this clearly is an unusual circumstance. that was partly impacted by the complexity of the the task order that we put in place which you just remember that that task order included reservation fee for a number of facilities including capital expenditure investment by the government and a number of our facilities includes us doing a lot of work for fill, finish, and drug product. So I think the complexity of the task order in large part impacted the timing. And at the end of the day, I think the government decided that they really didn't need that reservation. It took them a while to figure that out. And once they figured it out, we had a productive conversation and mutually agreed to end the task order and end the ADM contract.

And one follow-up question. Oh, sorry, sorry, go ahead.

Just to reinforce, and I think Bob mentioned this earlier, but we did believe that we were legally entitled to the full payment, but we did make a business decision in this circumstance after having discussions with the government that the most appropriate way to resolve the task order and the CIA relationship more broadly was to come to this arrangement.

And a final follow-up related to the chicken Guna vaccine, could you comment on the potential value of the market for the vaccine and who would be the customers? Thank you.

Yeah, Robert, thanks again. I'm going to let my colleague, Adam Habe, talk about that. Adam, again, is our chief operating officer, runs now and oversees all three of our business units. So, Adam, I think you're on the call if you could respond to that for Robert.

Sure. Thanks, Bob. Thanks, Robert, for the question. So, just as a reminder, the The Chikungunya virus is carried by mosquitoes like malaria and Zika, and the disease it causes can have both acute consequences and chronic ones, somewhat like Lyme disease, and that's why vaccination is really, really critical. There's a significant unmet medical need here, and we're looking at travelers from the U.S. alone, kind of pre-pandemic, where there are approximately 35 million unique travelers per year going to Chik endemic regions. And that's about three times the number for typhoid and almost a log greater than diseases like cholera. So we think it's a significant opportunity. We're developing our candidate based on that VLP technology that we've talked about. We believe it can deliver a really robust immunological response, have a good safety profile, and be very competitive in this market space. So we're excited about it and looking forward to getting the data and moving the product forward.

Thank you. Thanks Adam. Thanks Robert.

Again everyone, if you have questions, please press star 1 on your telephone keypad. I am showing no further questions at this time. I would now like to turn the conference back to Mr. Robert Burrows.

Thank you, Terry. 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. Thanks, everyone, again, for participating. We look forward to speaking with all of you in the future. Good night.

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