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Edited Transcript of EBS.N earnings conference call or presentation 5-Nov-20 10:00pm GMT

·45 min read

Q3 2020 Emergent BioSolutions Inc Earnings Call Rockville Nov 6, 2020 (Thomson StreetEvents) -- Edited Transcript of Emergent BioSolutions Inc earnings conference call or presentation Thursday, November 5, 2020 at 10:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Richard S. Lindahl Emergent BioSolutions Inc. - Executive VP, CFO & Treasurer * Robert G. Burrows Emergent BioSolutions Inc. - VP of IR * Robert G. Kramer Emergent BioSolutions Inc. - CEO, President & Executive Director * Syed T. Husain Emergent BioSolutions Inc. - Senior VP & CDMO Business Unit Head ================================================================================ Conference Call Participants ================================================================================ * Brandon Richard Folkes Cantor Fitzgerald & Co., Research Division - Analyst * Devin J. Geiman Guggenheim Securities, LLC, Research Division - Associate * Jacob William Hughes Wells Fargo Securities, LLC, Research Division - Senior Analyst * Jessica Macomber Fye JPMorgan Chase & Co, Research Division - Analyst * Keay Thomas Nakae Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Ladies and gentlemen, thank you for standing by, and welcome to the Emergent BioSolutions Inc. 3Q 2020 Earnings Conference Call. (Operator Instructions) Please note that today's (inaudible) I would now like to hand the conference over to your speaker, Bob Burrows, Vice President of Investor Relations. Please go ahead. -------------------------------------------------------------------------------- Robert G. Burrows, Emergent BioSolutions Inc. - VP of IR [2] -------------------------------------------------------------------------------- Thank you, Amanda, and good afternoon, everyone. Thank you for joining us today as we discuss the operational and financial results for the third quarter and 9 months ended September 30, 2020. 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 the webcast, there is a series of slides accompanying the webcast that we are pushing out to all webcast participants. During today's call, we may make projections and other forward-looking statements related to our business, future events or prospects for future performance. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. Any forward-looking statements speaks only as 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 Emergent's 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. The agenda for today's call will include Bob Kramer, President and Chief Executive Officer, who will comment on the current state of the company; Rich Lindahl, Chief Financial Officer, who will speak to the financials for 3Q and year-to-date 2020, as well as our updated guidance for full year 2020. And given the acceleration in the growth of our Contract Development and Manufacturing Services business, my colleague, Syed Husain, SVP and Head of the CDMO business, will provide a combination refresher as well as progress report on the status of this key BU. This will all be followed by a Q&A session where additional members of the senior team will be present and available as needed. Finally, for the benefit of those who may be listening to the replay of this webcast, this call was held and recorded on November 5, 2020. 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 our President and CEO, Bob Kramer. Bob? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [3] -------------------------------------------------------------------------------- Thank you, Bob, and good afternoon to everyone. Thank you for joining today's call. First and foremost, I want to take a minute at the beginning of the call here to acknowledge my Emergent colleagues for their hard work and dedication and their ongoing efforts to combat the global COVID-19 pandemic. In this challenging environment, our team has continued to excel. For more than 20 years, Emergent has prepared for threats like COVID-19. Our experience in addressing public health threats including our capabilities, our products, technologies and people is unparalleled. Also, it's worth noting a very special anniversary for Emergent. 50 years ago yesterday, BioThrax, the company's vaccine for immunization against disease caused by anthrax, was approved for use becoming the first and, to this day, only vaccine approved by the FDA for protection against anthrax. This important approval is a legacy that inspires all of us here at Emergent still today. So let's get started with the quarterly review. Overall, we continue to experience strength in our core business, including continued deliveries of our medical countermeasure products, coupled with substantial growth in the CDMO business, resulting in quarterly revenues of $385 million. Clearly, our strategy of diversification and profitable growth is fueling this strength as reflected in our strong quarterly and 9-month financial performance. Taking into consideration our year-to-date results and our visibility through to the end of the year, we also updated 2020 financial guidance, maintaining the same midpoint of $1.55 billion for total revenue for the year as well as increasing our profitability ranges. Rich will discuss all of this in greater detail in a minute. Beyond 2020, we remain well positioned and confident in our ability to achieve the long-term revenue and profitability guidance outlined late last year at our Analyst and Investor Day. With that as a backdrop, let me first turn to the CDMO business. And without stealing too much of Syed's thunder, we've experienced accelerated growth in CDMO revenues through the deployment of our capabilities in 3 key areas: first, development services; second, drug substance manufacturing; and third, drug product manufacturing. We signed approximately $1.5 billion worth of CDMO contracts since March in response to COVID-19 and continue to build upon that by securing approximately $60 million in new collaborations and existing product extensions -- project extensions during the quarter, which has led to continued revenue growth for the business during these last 2 quarters. We will continue to invest in this business unit and our facilities to increase our capabilities to meet the long-term expected demand and growth in this area. The CDMO business is well positioned for significant long-term growth, and you'll hear much more about this from Syed in a moment. Turning to the Devices business unit. There have been several recent events that provide additional confidence in the long-term prospects and value-creating potential for NARCAN Nasal Spray. Recently, we committed -- completed 2 important product life cycle improvements that we expect will provide meaningful value for our customers. First, we launched the Generation II NARCAN Nasal Spray device which is identified by a red plunger. It also has a claim for enhanced temperature excursions and storage below 25 degrees centigrade. Secondly, we gained FDA approval for an extension of the shelf life of NARCAN Nasal Spray from 24 months to 36 months. We expect these product enhancements to be meaningful factors in the product's long-term durability and continued growth. In addition to our internal progress, there have also been notable changes in the general naloxone landscape that we believe will be positive for the NARCAN Nasal Spray franchise. First, the recent FDA announcement requiring all labels for opioid pain medication, as well as medicine to treat opioid use disorder to be updated to include information about naloxone is an important incremental step at the federal level in pursuit of addressing this significant public health threat. Also new Canadian national consensus guidelines for proactive naloxone prescribing by pharmacists. The first ever guidelines of this kind of note were announced. These guidelines, released by a steering committee of pharmacists and recently published in the Canadian Pharmacist Journal, recommended all Canadian patients dispensed in opioid should also be given a naloxone kit and counseled by a pharmacist. These guidelines were issued in response to a disturbingly high number of opioid-related deaths across Canada, coupled with the difficulty for pharmacists in assessing the potential risk for opioid overdose. Unfortunately, the number of opioid overdose deaths continue to rise, due likely in part to the impact of the COVID-19 pandemic. We believe continued efforts to increase awareness, expand availability and maintain affordability of naloxone products like NARCAN Nasal Spray are more important than ever, and we remain steadfast in our commitment to having an impact in the fight against the threat of opioids. On the therapeutics front, we're committed to using our experience and platforms to rapidly advance treatments for COVID-19 that are intended to augment the natural antibody response to SARS-CoV-2. Our dedicated teams have made significant progress in advancing our COVID-HIG product candidate using our validated human hyperimmune platform. As announced earlier, we secured $15 million of funding from BARDA to develop COVID-HIG for a treatment indication and we were incredibly pleased to announce initiation of the Phase III clinical trial in partnership with NIAID. This pivotal clinical trial will evaluate the safety, tolerability and efficacy of hyperimmune product candidates as a potential treatment in adult patients hospitalized with COVID-19. Results from this study are expected in early 2021, depending on the recruitment of approximately 500 patients across multiple sites. Our partnership with BARDA and NAIAD will evaluate this potential treatment in patients at risk of progressing to severe disease in a second planned trial. This COVID treatment will also be used to evaluate for a second indication to prevent infections in individuals at high-risk of exposure, such as health care workers, military personnel and others. As previously announced, we have partnered with Mount Sinai Health System, ImmunoTek Bio Centers and the U.S. Department of Defense, which is providing approximately $35 million funding to rapidly advance this clinical program. The initial clinical evaluation of a dose in a PK/PD study is planned to initiate soon to be followed by a Phase II study to evaluate safety and efficacy of COVID-HIG in individuals at risk of exposure soon thereafter. Emergent has committed significant resources and expertise to quickly advance these treatment options for both indications and build a robust data set to support an application for emergency use authorization. In parallel to our efforts with COVID-HIG, we continue to advance our FLU-IGIV program as a potential treatment for patients hospitalized with severe influenza A. We completed the Phase II clinical trial earlier this year, and the data has been analyzed and reviewed with an external advisory board to inform potential next steps. The outcomes of the trial were generally favorable and supportive of progressing our discussions with regulators for plans for the next phase of development. As we advance both late-stage clinical candidates on the same platform, there are many insights that can be applied across both programs, and we're assessing the impact of the ongoing COVID-19 pandemic on the ability to execute on a trial for influenza. Turning next to the Vaccines business unit. We've continued to make deliveries of our anthrax vaccine candidate, AV7909, to the Strategic National Stockpile. In July this year, the U.S. government exercised an option to secure additional doses over the next 12 months. In parallel with delivering doses of this candidate into the stockpile, the clinical path continues on schedule. During the quarter, we completed the year 1 follow-up for the Phase III study and remain on track for submitting the BLA in 2021. With respect to our smallpox vaccine, ACAM2000. In May, the U.S. government exercised the second procurement commitment under last year's 10-year contract to secure additional doses for the Strategic National Stockpile. We expect all deliveries related to this action to be delivered in 2021. As to our travel health business, while it's a small contributor to our overall total revenue, it continues to be affected by the halt in global travel for the foreseeable future. Given this, we've taken steps to adjust this business accordingly. Specifically, we have restructured commercial components of this business which has led to cost reductions and some related onetime charges in the third quarter that Rich will discuss in more detail. Longer term, our conviction in the durability and strategic opportunity of travel health remains intact as we believe that COVID-19 will lead to an increased awareness for the importance of vaccinations for travel-related diseases. The business unit has a strong pipeline of products, and we expect to be well positioned for significant growth when conditions improve. As part of that effort, our lead travel health vaccines product candidate, CHIKV VLP, is progressing and remains on track for initiation of the Phase III clinical trial for this single dose vaccine for chikungunya in 2021. In summary, our diverse and balanced business model is showing its strength as well as its durability. Our operational and financial performance this year are the strongest in our company's history, and I couldn't be more encouraged by the prospects for continued growth and expansion as we continue on our path to protect and enhance the lives of 1 billion persons by 2030. I'll stop here and now turn the call over to Rich. Rich? -------------------------------------------------------------------------------- Richard S. Lindahl, Emergent BioSolutions Inc. - Executive VP, CFO & Treasurer [4] -------------------------------------------------------------------------------- Thank you, Bob. Good afternoon, everyone, and thank you for joining the call. I'm pleased to report that Emergent is sustaining the operational and financial momentum we highlighted on our last earnings call in July. As you've just heard from Bob, our employees are meeting the challenges of this unprecedented year and deploying our products, services and capabilities to help our country face the global pandemic brought on by COVID-19. Our financial performance during the third quarter and year-to-date in 2020 reflects the strength and durability of our diversified business as evidenced by solid year-over-year increases in total revenues, adjusted profitability, and operating cash flow. During the quarter, we strengthened our balance sheet by enhancing our liquidity and completing a highly successful inaugural bond offering. We have now refined our revenue guidance and raised our profitability outlook. As a result of all these factors, we are confidently moving forward and poised to extend our strong progress as we approach 2021. With that, let's first look at the details of our third quarter performance. Highlights include: total revenues of $385 million, an increase of $73 million or 24% versus the prior year; adjusted EBITDA of $168 million, an increase of $62 million or 58% versus the prior year; and adjusted net income of $119 million, a $54 million or 84% improvement versus the prior year. Breaking down quarterly revenue a bit further, let's review the elements of product sales. NARCAN Nasal Spray sales were $89 million, reflecting strong and durable demand for this critical drug-device combination product for opioid overdose reversal; anthrax vaccine sales were $74 million, reflecting the strong delivery volumes associated with the continued transition from BioThrax to AV7909 in the Strategic National Stockpile; ACAM2000 sales were substantially lower-than-expected due to a timing delay that will push deliveries into the fourth quarter of this year and possibly into 2021; and other product sales were $39 million, primarily reflecting sales of VIGIV and BAT. In addition to the increase in product sales, we also had significant growth in CDMO services as revenues increased to $157 million in the quarter. These results reflect the continuing contribution from the approximately $1.5 billion of contract value related to COVID-19 secured since March, most notably, our landmark public-private CDMO partnership with BARDA in support of the U.S. government's Operation Warp Speed program, as well as the tech transfer and commercial supply agreements with Johnson & Johnson and AstraZeneca. Looking beyond revenue, the quarterly results also include combined product and CDMO gross margin at 59%, reflecting the impact of overall product mix as well as improved contribution from CDMO services offset by certain nonrecurring charges, which I will detail in a moment. Excluding these onetime items, adjusted gross margin was 71%. Net R&D expense of $30 million or 8% of adjusted revenue, reflecting discretionary development investments, primarily in our COVID-19 therapeutic product candidates. And SG&A spend of $76 million or 20% of total revenues, which increased 16% since last year, driven by additional staffing to support our growth. As you will note on the reconciliation tables toward the end of our earnings press release, there are several onetime items that are included in our third quarter results. First, we increased our contingent consideration liability by $30 million to reflect our expectation that the second and final milestone related to the Adapt Pharma acquisition will likely be paid in full; second, we took a $29 million noncash impairment charge related to our naloxone prefilled syringe development program that we are continuing to evaluate; and third, we incurred $17 million of exit and disposal costs associated with managing our travel health business during the pandemic, including $14 million of noncash inventory write-down costs. Our financial performance for 9 months of 2020 was also very strong, driven by all the factors just discussed for the third quarter. Key highlights include: total revenues of $972 million, an increase of $227 million or 30% compared to last year; total product sales of $649 million, up $56 million or 9%. This includes $258 million from anthrax vaccines, $234 million from NARCAN Nasal Spray, $71 million from ACAM2000 and other product sales of $86 million. It is worth highlighting that sales of anthrax vaccines are up significantly versus the prior year, reflecting continued deliveries of AV7909 as part of the SNS transition to this product, which was first delivered in Q3 2019. Additionally, we realized a 10% increase in sales of NARCAN Nasal Spray, driven primarily by demand from public interest customers. CDMO services revenue of $251 million reflects the significant expansion of this business through the recently announced arrangements across development services, drug substance manufacturing and drug product manufacturing, primarily in response to the COVID pandemic. As a reminder, and as you will hear shortly from Syed, these new collaborations, along with recent extensions of existing projects, reflect continued penetration of the addressable $20 billion CDMO market opportunity with a balanced mix of clinical and commercial activities. And combined product and CDMO gross margin of 60%, reflecting the impact of mix and the improved contribution from CDMO, offset by onetime charges described earlier. Excluding these items, year-to-date adjusted gross margin was 66%. The year-to-date financial results also include net R&D expense of $74 million or 8% of adjusted revenue, reflecting investments in our chikungunya product candidate and COVID-19 therapeutic product candidates, offset by reduced spend related to our FLU-IGIV product candidate. SG&A expense of $221 million or 23% of total revenues compared to 27% in the prior year, reflecting continued scaling of our business, even with an increase in share-based compensation and continued investment in staffing to support our growth. And in terms of year-to-date profitability, adjusted EBITDA of $340 million or 35% of total revenues and adjusted net income of $225 million or 23% of total revenues. Turning to our balance sheet. We ended the quarter in the strongest liquidity position in the company's history with combined cash, accounts receivable and available borrowing capacity exceeding $1 billion. Our liquidity position was significantly enhanced during the quarter as a result of our issuance in August of $450 million of senior unsecured notes due in 2028, which enabled us to fully refresh the borrowing capacity under our $600 million revolving credit facility. We ended the quarter with $415 million in cash and accounts receivable of $196 million, bringing current liquid assets to over $600 million. And our net debt position at September 30 was $476 million, a reduction of 27% from December 31. As a result, and based on the midpoint of our updated full year guidance, we are on track to achieve a ratio of net debt to adjusted EBITDA of less than 1x for the full year of 2020. Our cash flow highlights include year-to-date operating cash flow of $291 million, which is also the strongest in our history and reflects the substantial cash generation capability of our current product and services mix. In addition, year-to-date capital expenditures of $105 million reflects a variety of capacity and capability expansions that we have previously discussed, principally our ongoing projects to scale the CDMO business sites in Maryland and Massachusetts. And free cash flow, which we define as operating cash flow less CapEx, was $186 million in the first 9 months of the year, or 12x the level realized in the first 9 months of 2019. In sum, our accelerating operating momentum creates favorable conditions for us to execute on our growth strategy and deliver solutions to address global public health threats. I'll now move on to our updated guidance. Taking into consideration the performance for the first 9 months of the year, our outlook for the remainder of the year across all of our business units and the expectation that challenges in some parts of our business will be offset by expansion in other parts, we are updating our 2020 full year forecast. This forecast consists of the following elements. Total revenues narrowed to a range of $1.52 billion to $1.58 billion, maintaining the midpoint of $1.55 billion. In terms of product-specific detail, anthrax vaccine sales in the range of $350 million to $370 million, an increase of $25 million versus the midpoint of the prior range, reflecting our improved visibility into this year's anticipated deliveries of AV7909, as we continue to gain more experience with this development stage product candidate; NARCAN Nasal Spray sales in the range of $295 million to $315 million, an increase of $5 million at the midpoint, reflecting greater visibility into this year's shipments to both retail and public interest channels; and ACAM2000 sales in the range of $160 million to $200 million, a decrease of $10 million at the midpoint, reflecting the possibility of fewer ACAM doses available for shipments this year than previously anticipated due to a timing issue; for the CDMO business, revenues in the range of $450 million to $470 million, an increase of $10 million at the midpoint, reflecting the timing of certain activities and additional business acquisition and project extensions to be realized this year. Our profitability guidance includes: Adjusted net income of $375 million to $405 million, an increase of $25 million at the midpoint versus the midpoint of the prior range; and adjusted EBITDA of $575 million to $615 million, an increase of $28 million at the midpoint and a further clear indication of the earnings potential of our overall diversified operations. Importantly, our revised 2020 guidance takes into account the following operational considerations, which have not changed since July when we last spoke to guidance. Improvement of full year gross margin by 400 to 600 basis points, driven by product mix and increased contribution from our CDMO business; the previously announced delay into 2021 of the launch of the Phase III clinical study for the CHIKV VLP program due to the timing of certain operational factors; the continued deferral into 2021 of a follow-on procurement contract with the U.S. government for raxibacumab, due to the impact of the prioritization of the Operation Warp Speed program on our efforts to tech transfer the raxi process to the Bayview, Baltimore site; continued significant disruption of global travel for the entirety of 2020 which greatly reduces Vaxchora and Vivotif revenues; and finally, an assumption of no generic competition in 2020 for NARCAN Nasal Spray. In conclusion, we at Emergent are committed to building a strong and resilient business with the capabilities, capacities and financial strength needed to deliver preparedness and response solutions to public health threats. Our current outlook and recent accomplishments for tangible evidence of the durability and viability of our unique business model and the role that we play in protecting and enhancing lives across the globe. We are executing on our mission and sustaining solid operating and financial performance as we approach the end of 2020 and move confidently into 2021. That completes my prepared remarks. And I'll now turn the call over to my colleague, Syed Husain, who will take us through an overview and update on the CDMO business, including, for the first time, certain key metrics regarding the health of this business unit. Syed? -------------------------------------------------------------------------------- Syed T. Husain, Emergent BioSolutions Inc. - Senior VP & CDMO Business Unit Head [5] -------------------------------------------------------------------------------- Thank you, Rich. Good afternoon to everyone. Thank you for joining today's call. I'm incredibly pleased to be here today to provide a deep dive into the CDMO business. As Bob noted earlier, we have demonstrated significant revenue and portfolio growth by deploying our expertise across development services, drug substance manufacturing and drug product manufacturing with both industry and government customers. While much of the recent growth has been driven by collaborations on COVID-19 programs, I want to emphasize the durability and sustainability of our CDMO business. Our ongoing investment in both capacity and new capabilities will increase our ability to meet the expected long-term demand, leading to significant long-term growth. I'll start my remarks with a key factor that has led to our current success and will continue to be a differentiating factor going forward. As an integrated CDMO, Emergent occupies a particularly unique position in the landscape, combining the customer focus and dedication of a pure-play CDMO with the expertise and experience of a CDMO embedded in a pharma company. We have the distinct mindset to provide services to bring products all the way from concept to market. There is no other CDMO with this unique position in the landscape and resulting value proposition. Next, I'd like to highlight that we are trying to address a $20 billion market opportunity. The approximate dollar value for each of the components is shown on the slide, so I'm not going to address each one separately. Individually, they all represent sizable markets, and we are confident in our ability to increase our long-term market share in each. Our confidence is based on several factors. First, we have an extremely successful track record of development and manufacturing abilities. Bob alluded to the history of Emergent in his comments, and that legacy continues to benefit us to this day. We also have an enterprise team of more than 1,400 technical and quality compliance professionals, a vital key to our success. Another advantage is the location of our facilities and capabilities that are in close proximity to pharma and biotech hubs. Finally, we possess a unique biologics platform of technologies with customizable offerings across the entire drug development life cycle. In the next couple of slides, I'll give a brief overview of the CDMO business. For those interested in more detail, the slides and transcript from our 2019 Analyst and Investor Day are available on our IR website. This slide shows the broad and varied offerings we provide to our customers, allowing for end-to-end integrated services. With 3 molecules to market service offerings, 5 technology platforms and 9 development and manufacturing sites, we have the foundation to meet the individual needs of our customers now and into the future. Given time constraints, I'm not going into detail on our service offerings, but do want to note 3 main buckets: development services; drug substance manufacturing; and drug product manufacturing and packaging. Again, offering 1, 2 and or all 3 services allows us to rapidly partner and collaborate with customers from concept to commercialization, which we describe as molecule-to-market. The next slide shows a high-level overview of our facilities, which are spread across 9 locations in the United States, Canada and Switzerland. While this slide reinforces the substantial expertise in infrastructure already in place, importantly, it also shows the significant opportunity for expected further investments as evident with our active investments at 3 of our facilities: Viral vector and gene therapy drug substance manufacturing at our Canton, Massachusetts facility; nonviral drug product manufacturing at our Baltimore, Maryland Camden facility; and viral drug product manufacturing at our Rockville, Maryland facility. This will allow us to increase our capacity to deliver on future business opportunities in the coming years. As a reminder, presently, we are only in -- only 1 year into the relaunching of this business to realize the full potential of our broad network of sites as well as growing capabilities and capacities. At the Analyst and Investor Day, I laid out a series of key initiatives that we believe will drive market penetration and lead to future growth. I'm going to quickly reiterate those now. Continued expansion of our sales and business development team is a key initiative. We now have many experienced professionals in place, and we are already seeing their impact on our funnel of future agreements. We will continue to enhance our molecule-to-market offerings, which is vital and will provide additional opportunities for our sales and business development team to interact with both existing and potential customers. Growth with existing clients through cross-selling is at the heart of our strategy and a scalable business. Not many CDMO organizations can match the breadth of Emergent's technologies. To support our sales and business development teams, we are focused on increasing brand awareness and expansion within the United States and internationally through innovative marketing, including the virtualization of the sales and marketing process. We are expanding the appropriate levels of the organization to increase our targeting of small and midsized pharma and biotech, as these companies are at the heart of innovation and key in our concept to market strategy. We will continue to invest as appropriate to both meet the evolving market needs and increase capacity in order to meet expected longer term demand. In conjunction, we will also explore partnership opportunities to further enhance our offerings. Remaining innovative is key, so we will be actively pursuing efforts in gaining access to novel technologies and extend our offerings. Finally, we will maintain a balance between clinical and commercial projects. While commercial projects provide more stable revenues, earlier-stage programs provide substantial opportunities for more client interaction and cross-selling and will drive the long-term growth of the unit via a diversified portfolio. Our next slide shows our strong current portfolio through the efforts of executing our commercial strategy. By portfolio, we mean secured business with guaranteed minimums and forecasted business. As a snapshot through Q3 2020, with approximately 57 customers, 71 molecules and 83 projects, the CDMO business is diversified and not overly reliant on a particular offering. The total value of the CDMO portfolio at present is approximately $1.8 billion, including approximately $60 million in new molecule collaborations and existing project extensions secured within the quarter. We have already recognized approximately $250 million of these revenues this year and expect to realize the remainder from these projects both this year and into the years ahead. We are providing this data as we believe it is important for investors to judge our progress in the business. Importantly, we are evaluating how often to update on these metrics in the future. We are also providing our current funnel of opportunities to give insight into the considerable number of potential programs currently in negotiation that we believe have a reasonable probability to enter the portfolio in the near term. As a reminder, the team works to continuously increase our opportunity funnel through prospecting efforts across the pharma and biotech and government/nongovernment agencies customer segments, with all of our offerings and network of development and manufacturing facilities. I want to highlight that as with our current portfolio, there is a nice mix in terms of customers, molecules and projects including active discussions for our capabilities and capacities in facilities not routinely referenced, such as Lansing, Michigan and Winnipeg, Canada, as well as our active investments in Rockville, Maryland and Canton, Massachusetts. As a snapshot through Q3 2020, the total potential value of the funnel at present is approximately $500 million. I'd like to stress that our current portfolio and opportunity funnel do not tell the full story. 2 key items to highlight. First, the previous values I discussed do not include existing project extensions from our current portfolio of customers like Johnson & Johnson or AstraZeneca, which could be sizable. Also, there is a substantial amount of prospecting discussions ongoing, we could also -- which could also enter the opportunity funnel or portfolio shortly. We are enthusiastic in this regard as we are experiencing a steady increase in inquiries and interest for our CDMO services especially our mammalian and viral technology platforms in development services, drug substance and drug products. Finally, as shown on this slide, I'd like to highlight the key takeaways. We are very pleased with the progress made in the CDMO business in less than a year, and we remain incredibly confident in our ability to execute in delivering on our growth initiatives. Our current portfolio of approximately $1.8 billion provides a solid base over the upcoming years. Our current funnel of opportunities is approximately $500 million, not including potential existing project extensions. Also, we are committed to further investment in the business of greater than $200 million to provide expansion of capacity and capabilities. The ongoing expansion of our sales and business development efforts should increase our opportunity funnel further and secure additional business. We believe this will lead to both market share penetration and long-term growth. We look forward to updating all of you on future progress in the coming quarters. With that, I will turn the call over to the operator to begin the question-and-answer session. Operator? -------------------------------------------------------------------------------- Robert G. Burrows, Emergent BioSolutions Inc. - VP of IR [6] -------------------------------------------------------------------------------- Amanda, are you there, please? Operator? ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) And your first question comes from Jacob Hughes with Wells Fargo Securities. -------------------------------------------------------------------------------- Jacob William Hughes, Wells Fargo Securities, LLC, Research Division - Senior Analyst [2] -------------------------------------------------------------------------------- Maybe if we could just have 2 questions. One is on NARCAN. If we take the mid to high point of your guidance, it implies some softening in the fourth quarter from the third quarter. Maybe if you could just talk about the key drivers of that? And then on the CDMO business, maybe you could provide some additional detail on the cost that you're currently incurring related to your COVID-19 contracts? And then longer-term if a vaccine is successful, how should we think about the economics on a per dose basis for those contracts? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [3] -------------------------------------------------------------------------------- Yes. This is Bob. Thanks, Jacob, for the questions. Thanks for joining the call. So on the first one, the Q3 versus implied Q4 NARCAN. First of all, the Q3 revenues for NARCAN were at an all-time high of roughly $89 million, roughly 10% above Q2. As we talked about throughout the year, our annual view and guidance on NARCAN was predicated on a couple of things. First of all, that there would be no generic entrant or competitor to NARCAN Nasal Spray during 2020. Second, that there would be a couple more states that would adopt co-prescription, either policy or legislation, which could potentially give a bit of a lift to the overall revenues. So we continue to be quite bullish and optimistic for that franchise in that product. I think what you might be implying in our Q4 number that you backed into it, it is maybe a little lower than $89 million. But again, we'll continue to monitor. What I will say is, in Q3, both the retail component of NARCAN Nasal Spray revenues as well as the public interest market were higher in part on the PIP market, driven by some of the state programs in California, in New Jersey, in Michigan and Georgia. So again, we're quite optimistic. On COVID-19 and the contracts. In terms of the economics, I guess, I would say that we continue to evaluate the economics and what that additional revenue brings to the business. Our sole focus right now during the first, really, 8 months of these contracts has been to make sure that we are honoring our commitments and obligations to stand up a many -- a robust manufacturing process and supply chain here in the United States for a number of our collaborators, including J&J and AZ. We'll evaluate longer term the economics of what those contracts might look like under the commercial supply agreement. But as we have commented on, right now, those contracts in addition to the contract with BARDA and OWS are meaningfully contributing to both revenue and profitability during 2020, and we expect the same for 2021. -------------------------------------------------------------------------------- Operator [4] -------------------------------------------------------------------------------- And your next question comes from Jessica Fye with JPMorgan. -------------------------------------------------------------------------------- Jessica Macomber Fye, JPMorgan Chase & Co, Research Division - Analyst [5] -------------------------------------------------------------------------------- I appreciate you providing that additional detail on the CDMO business. I'm trying to better understand the potential for near-term upside from that business. I think you said you're investing in building on sites in Maryland and Massachusetts. So how much of your capacity is spoken for at this point? And how much do you think you could still contract out over the next kind of year or 2? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [6] -------------------------------------------------------------------------------- Sure. Thanks, Jess, for the question and good to hear your voice again, welcome back. I guess on the capacity issue, it suggests that you will look at this a couple of different ways. First of all, as Syed has articulated, we have a fairly broad and diverse network of 9 different CDMO development and manufacturing sites. And as you know, just from following us for quite some time, all of those manufacturing sites are a bit different. If you talk about capacity for COVID-19, vaccine development manufacturing in Bayview, which is where the majority of that work is being done. I think we've said out loud that we're pretty much capacity maxed out right now with the work that we're doing with J&J, with AZ, with Novavax and as well as with Vaxart. How that looks going forward will be somewhat dependent upon what the eventual yield is for many of those products. But I'll turn it over to Syed. He can comment more -- in more detail about the other kind of non COVID-19 sites, including what we're doing in Canton to build that site out for future development. -------------------------------------------------------------------------------- Syed T. Husain, Emergent BioSolutions Inc. - Senior VP & CDMO Business Unit Head [7] -------------------------------------------------------------------------------- Thank you, Bob, and thank you for the question. Just -- so the perspective that I would add on top of Bob's comment is to really reiterate the network effect from a utilization standpoint. So if you go back to my prepared comments with respect to, first off, the offerings. So we have 3 distinct offerings between development services, drug substance and drug product. The ability to offer those individually and in an integrated fashion across all the technologies allows us to still continue to onboard new business across the network that we have. That $500 million funnel is spread across opportunities that could go across our network. And that even takes into account, as I mentioned, facilities that we don't routinely reference, such as the one in Lansing, Michigan as well as Winnipeg, Canada. And it also takes into account facilities that are coming on stream based on our committed capital investments. So for example, the expansion in Rockville, Maryland is coming on stream at the end of 2021. The investment in Canton, Massachusetts, which really puts us into advanced therapies from a gene therapy standpoint, comes online in 2023. So this network as well as our ability to partner with customers across each of these offerings, as well as the $500 million funnel will allow us the opportunity to, over the years including this year and next year, continue to leverage available capacity that we have and be set up to utilize capacity that's coming on stream with the committed investments. -------------------------------------------------------------------------------- Jessica Macomber Fye, JPMorgan Chase & Co, Research Division - Analyst [8] -------------------------------------------------------------------------------- Okay. Got it. Just 2 kind of follow-ups to that. How flexible are the suites you're building out for the COVID vaccines? And to the extent that those partners ended up not meeting your capacity, can you help us understand how simple or complicated it would be to switch over that capacity to other products for a different client? And then the last question is, just what's the current operating margin for the CDMO business? And what do you think of it as on a normalized basis? -------------------------------------------------------------------------------- Syed T. Husain, Emergent BioSolutions Inc. - Senior VP & CDMO Business Unit Head [9] -------------------------------------------------------------------------------- Absolutely. So I'll answer the first question and then pass it over to my colleague, Rich, for the second one. With respect to the first question. All of our development and manufacturing facilities are predicated on being multi purpose. So they are designed to handle multiple products. They have foundational technology platforms that then allow them to be customized for the specific product and process that we're working on. And specifically, when we talk about the drug substance facility in Baltimore, which is known as our Bayview facility. So right now, that is predicated on multiple products being in there. If for any reason, those products are not successful, certainly with our deal structures that we've provided information on previously, we're protected from a financial standpoint. But then also given the fact that they're multi purpose facilities, we can pretty readily transition to other opportunities either through those same innovators or opportunities that are in our funnel. And in parallel to that, while we focus our efforts on our drug substance facility, we're able to onboard new relationships and development services and in drug product as we've done over the past quarter. -------------------------------------------------------------------------------- Richard S. Lindahl, Emergent BioSolutions Inc. - Executive VP, CFO & Treasurer [10] -------------------------------------------------------------------------------- Yes. And in terms of the profitability of CDMO. So on a normalized basis, longer term, we would expect the margins to be in the 45% area, somewhere in the mid-40s with an opportunity to improve from there. As we look at this year and next year, we're experiencing better margins than that, just driven by a number of factors, including the fact that because the facilities are so highly utilized right now, there's a much higher degree of absorption of the overhead in those facilities as well as some benefits we're receiving on some of the capacity reservation fees. So several clicks higher this year and next year, major contributor to that 400 to 600 basis point blended gross margin improvement. And that's -- but on a longer-range basis, more normalized than kind of the 45%, maybe higher-margin area. -------------------------------------------------------------------------------- Operator [11] -------------------------------------------------------------------------------- Your next question comes from Brandon Folkes with Cantor Fitzgerald. -------------------------------------------------------------------------------- Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [12] -------------------------------------------------------------------------------- Congratulations on the quarter. I'll change pace a little bit here. You talked about the headwinds in the travel vaccines business, and that's completely understandable just given the environment. Does that change how you're thinking about the development time line for your chikungunya products? Is this something you may look to push out just given what is going on with the travel world? Any color there just in terms of what we should expect would be great. -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [13] -------------------------------------------------------------------------------- Yes. Thanks, Brandon, for the question, and thanks for joining the call. And we continue, obviously, to evaluate our ability to execute the development plan for the chikungunya candidate. Our best information tells us that we should be able to start that clinical trial in 2021. And clearly, I think you're right in identifying that there may be some risk to starting that because of the macro issues around COVID-19. But I mean again, as we stand here today, we plan on initiating in 2021. -------------------------------------------------------------------------------- Operator [14] -------------------------------------------------------------------------------- And your next question comes from Keay Nakae with Chardan. -------------------------------------------------------------------------------- Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [15] -------------------------------------------------------------------------------- I just want to talk about some of the guidance for some of the product revenue. Bob, your anthrax vaccine travel guidance, much higher. What does this imply for next year? Generally speaking, we do see these numbers on a year-over-year basis fairly steady. This is going to be an upsized year. How do we think about 2021? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [16] -------------------------------------------------------------------------------- Yes, Keay, thanks for joining the call. So let's take 1 year at a time. I mean, 2020, as you note, we were able to increase the range from last quarter from -- it was $320 million to $350 million, now it's $350 million to $370 million. So again, I will readily acknowledge that. But I will also acknowledge that on ACAM2000, we had to take a little bit of a haircut on the bottom side of the range. And this is all due to our best view of our ability to meet delivery schedules and to supply the appropriate number of doses for, in this case, both anthrax vaccines as well as ACAM2000. And you know from our many years of conversations, the risks associated with the supply chain around biologic products whether it's the production cycle or the testing cycle or regulatory and review cycles, it ebbs and flows a bit. So there's a little bit of variability around that. And we've been able to manage that effectively when it comes to anthrax vaccines in 2020 to the point where we were able to up the guidance a bit. And as Rich indicated, with ACAM2000, the smallpox vaccine, we've provided essentially a little bit of a different range just in recognition of some of the supply chain challenges that go with biologics. So we will give some guidance, as we always do for 2021, probably in early January of next year. As we've talked about in the past, we expect there to be -- the run rate for anthrax vaccines, which have historically been in that $250 million to $300 million range, we expect that going forward. I think what we're experiencing in 2020 is a little bit of maturity, quite frankly, in the transition of the Strategic National Stockpile from BioThrax only to a BioThrax and AV7909 stockpile. So it's just part of the evolution, the maturity of that transition, Keay. -------------------------------------------------------------------------------- Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [17] -------------------------------------------------------------------------------- Okay. So we shouldn't necessarily think that the upsized 2020 number is eating too much into what we would normally think on an average basis for 2021? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [18] -------------------------------------------------------------------------------- Yes. We'll talk about 2021 in a couple of months. -------------------------------------------------------------------------------- Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [19] -------------------------------------------------------------------------------- Okay. Switching to raxi. You mentioned with the focus on COVID-19 and the impact on getting the follow-on contract, how far out should we think about that follow-on contract now being -- in terms of being able to secure that? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [20] -------------------------------------------------------------------------------- Yes. I would hope that sometime during 2021, we'll get clear line of sight in terms of the overall procurement and contracting process. I think it -- in part, it's impacted by the more macro issues around COVID-19. So we'll hope to flatten that out in the first half of 2021. -------------------------------------------------------------------------------- Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [21] -------------------------------------------------------------------------------- Do you need to have advance the U.S.-based manufacturing to a certain point before you're able to successfully complete that contract? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [22] -------------------------------------------------------------------------------- And you're back on raxi now, Keay? -------------------------------------------------------------------------------- Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [23] -------------------------------------------------------------------------------- Yes. Yes. Sorry, Bob. Yes. -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [24] -------------------------------------------------------------------------------- Yes, we will. As we've talked about in the past, our plans were to do a tech transfer from GSK to our Bayview facility. And right now, the Bayview facility, as Syed articulated, is essentially full up and fully committed to COVID-19. So we'll work through the issues. I think we'll have, again, clear line of sight in the first half of 2021 what the long term implications, if any, for raxi will be. -------------------------------------------------------------------------------- Operator [25] -------------------------------------------------------------------------------- (Operator Instructions) Your next question comes from Dana Flanders with Guggenheim Partners. -------------------------------------------------------------------------------- Devin J. Geiman, Guggenheim Securities, LLC, Research Division - Associate [26] -------------------------------------------------------------------------------- This is Devin on for Dana. Just a few for me today. First, the midpoints of your guidance imply, I believe if my math is correct, sequential decline in 4Q EBITDA margins. Could you provide some color on what's driving that step down sequentially? And is this just a function of mix and lower relative contributions of CDMO in terms of percent of overall revenues or something else? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [27] -------------------------------------------------------------------------------- Yes, Devin, thanks for joining the call. Thanks for the question. Yes. I'll make a couple of comments, and then I'll ask Rich to weigh in as well. I think it's important to note that, in fact, we have guided up the adjusted EBITDA number for 2020, even from quarter 2 earlier this year which was significantly higher than what we guided initially in the beginning of 2020. So I think what you're probably referring to is when you start doing the math and backing in to what a Q4 number looks like, given the large revenue contribution, again, as a result of backing into the number, maybe the margin looks a little out of line, particularly if you look at it compared to Q3. I wouldn't read anything into that. It will be the result of mix of contributions, but I wouldn't read much into that, Devin. -------------------------------------------------------------------------------- Richard S. Lindahl, Emergent BioSolutions Inc. - Executive VP, CFO & Treasurer [28] -------------------------------------------------------------------------------- Yes. I mean, I -- we can go through that with you off-line, but we are not expecting a decline -- a sequential decline in the adjusted EBITDA margin in the fourth quarter. -------------------------------------------------------------------------------- Devin J. Geiman, Guggenheim Securities, LLC, Research Division - Associate [29] -------------------------------------------------------------------------------- Okay. And then I guess just one follow-up. So on the CDMO business, I know you guys mentioned -- I didn't have the slides up, but the -- you mentioned $1.8 billion in current portfolio, $60 million in new business and existing projects and a funnel of approximately $500 million. I'm assuming that the $1.8 billion includes the COVID contracts. But is there any other COVID-related business that rolled up into those other, I guess, into the funnel or into the new contracts you signed this quarter? -------------------------------------------------------------------------------- Robert G. Kramer, Emergent BioSolutions Inc. - CEO, President & Executive Director [30] -------------------------------------------------------------------------------- So at a high level, you are correct. The $1.5 billion in COVID-19 contracts that we've announced and press released during the first 9 months of this year are included in the $1.8 billion. Syed, I don't know if you have additional color or detail you want to comment about the remaining $300 million in terms of what's COVID versus what's non COVID? -------------------------------------------------------------------------------- Syed T. Husain, Emergent BioSolutions Inc. - Senior VP & CDMO Business Unit Head [31] -------------------------------------------------------------------------------- Yes, absolutely. Thank you, Bob. So a couple of things. With respect to that 1 point -- approximately $1.8 billion, of that, $300 million that's separate from the COVID response, that is predominantly non COVID. The other aspect is that $1.8 billion -- approximately $1.8 billion does not include existing project extensions from our current portfolio of customers like Johnson & Johnson or AstraZeneca, which could be sizable. From an opportunity funnel standpoint that we had talked about, which is as a snapshot right now approximately $500 million, we see a very diverse set of discussions within that $500 million. That does include some additional COVID opportunities as well as a very healthy mix of non COVID opportunities as well. -------------------------------------------------------------------------------- Operator [32] -------------------------------------------------------------------------------- And there are no further questions. I would now like to turn the conference back over to Bob. -------------------------------------------------------------------------------- Robert G. Burrows, Emergent BioSolutions Inc. - VP of IR [33] -------------------------------------------------------------------------------- Thank you, Amanda. 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 the 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. Thank you all again, and we look forward to speaking with all of you in the future. Goodbye. -------------------------------------------------------------------------------- Operator [34] -------------------------------------------------------------------------------- That does conclude today's call. You may now disconnect.