Emergent BioSolutions Inc.
Q3 2021 Earnings Call Transcript

Published: 4 Nov 2021

[Operator:]

Ladies and gentlemen, thank you for standing by, and welcome to the Emergent BioSolutions Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. I would now like to hand the conference over to the company. Please proceed.

[Bob Burrows:]

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 Emergent BioSolutions. In addition to today's press release, there is a series of slides accompanying this webcast available to all webcast participants. Turning to slides 3 and 4. 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 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. Turning to Slide 5. 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 and Rich Lindahl, Chief Financial Officer who will speak to the financials for 3Q 2021 as well as the forecast for full year 2021. 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 6. Bob?

[Bob Kramer:]

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 Center for Innovation in Advanced Development and Manufacturing or CIADM program with the US government. My comments are summarized across slides 7 and 8 in the deck accompanying the call. So let's get started. As you've seen this year, our Emergent team and our business have 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 US government on two core medical countermeasure products. First, we received the contract modification exercising and funding the second of nine annual options to supply ACAM2000 to the Strategic National Stockpile valued at approximately $182 million. Secondly, we received a contract modification exercising and funding the procurement of additional doses of AV7909 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 III trial for our chikungunya vaccine CHIKV VLP, a key milestone for us because it's the first Phase III 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 travel health vaccines franchise. And finally, we continue to grow our CDMO operations securing a new multiyear 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'll 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 time frame never before attempted under very challenging conditions. Our COVID-19 work with BARDA under the CIADM program included a number of activities. These included

[Rich Lindahl:]

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 ACAM2000 option exercise in July and the AV7909 contract modification on September 30. 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 III 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 US government to terminate the CIADM contract and associated task orders. As we disclosed in an 8-K filed 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 30, 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

[Operator:]

Your first question comes from the line of Brandon Folkes with Cantor Fitzgerald. Your line is now open.

[Brandon Folkes:]

Hi. Thanks for taking my questions. Maybe firstly just on the CIADM contract can you maybe just elaborate in terms of your relationship with HHS and maybe the individuals responsible for that contract versus any impact on your relationship with the Strategic National Stockpile? Just any clarification on the statement that there's reversal of the revenue base due to lack of cash collection, did they stop paying you before the mutual termination of that agreement? And then secondly maybe just on Narcan 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.

[Bob Kramer:]

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, 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 the best way forward was to kind of end the task order and 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 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.

[Rich Lindahl:]

Yeah. So Brandon to answer your question, yes, the government had been behind on payments related to the task order. 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 actually collected, there was a difference of $86 million which we reversed in the third quarter.

[Bob Kramer:]

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 kind of naloxone 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 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.

[Brandon Folkes:]

Great. Thank you. I appreciate the additional color. Thank you.

[Bob Kramer:]

Thanks Brandon.

[Operator:]

Your next question comes from the line of Jessica Fye from JPMorgan. Your line is now open.

[Jessica Fye:]

Hey guys. good evening. Thanks for taking my questions. So, appreciate you kind of bridging us from the -- 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 time frame 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?

[Bob Kramer:]

Yes Jess. Thanks. 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.

[Jessica Fye:]

Okay, great. And maybe just two more. One following up on the last question on NARCAN. Maybe 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 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?

[Rich Lindahl:]

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

[Jessica Fye:]

Okay.

[Bob Kramer:]

Yes. Jess on your first question regarding NARCAN and I guess our view that its core, I'll say a couple things. 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, $400 million in revenue projected for this year. The range of $400 million to $420 million 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 an authorized generic and generic competing in the retail space and some pressure and some competition in the public interest market, for us it's still a sizable asset going forward. And that is notwithstanding the fact that we continue to look for additional assets and additional lifecycle management opportunities for NARCAN Nasal Spray including 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.

[Jessica Fye:]

Thank you.

[Bob Kramer:]

Thanks Jess.

[Operator:]

Your next question comes from the line of Keay Nakae from Chardan. Your line is now open.

[Keay Nakae:]

Hi, guys. Thank you. A couple of questions just to 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?

[Bob Kramer:]

Yeah. I think Keay -- 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 going to lose some market share. We'll gain some back with our authorized generic. That dynamic again is going to be we think, different in the public interest market for the reasons they articulated. Not that it's going to 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.

[Keay Nakae:]

Okay. And just going back also to an earlier question about your relationships. How would you characterize the strength of your relationship with the people over at ASPR?

[Bob Kramer:]

Yeah. Keay, 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 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 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 in at us were concerned that the challenges that we've had with COVID-19 response were going to somehow impact that core of the business. That's clearly not the case. And we move forward.

[Keay Nakae:]

Okay. Final question. For your hyperimmunes for COVID, I know COVID-HIG recently went into a Phase 3. Are you still doing development work for COVID-EIG?

[Bob Kramer:]

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

[Keay Nakae:]

Great. Thanks.

[Operator:]

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

[Robert Maltbie:]

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

[Bob Kramer:]

Yes. 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've followed us 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 task order that we put in place, which just remember that that task order included reservation fee for a number of facilities, including capital expenditure investment by the government in a number of our facilities. It included us doing a lot of work for fill/finish and drug products. 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.

[Robert Maltbie:]

And one follow-up. Sorry, sorry go ahead.

[Rich Lindahl:]

Well, 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 CIADM relationship more broadly was to come to this arrangement.

[Robert Maltbie:]

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

[Bob Kramer:]

Yes, Robert. Thanks again. I'm going to let my colleague Adam Havey talked about that. Adam again is our Chief Operating Officer, who 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.

[Adam Havey:]

Sure. Thanks Bob. Thanks Robert for the question. So just as a reminder the chikungunya virus is carried by mosquitoes like malaria and Zika. The disease it causes can have both acute consequences and chronic ones somewhat like Lyme disease or -- 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 US 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 a much -- almost a log greater than diseases like cholera. So there's just a -- 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, 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.

[Robert Maltbie:]

Thank you.

[Bob Kramer:]

Thanks, Adam. Thanks. Robert.

[Operator:]

I am showing no further questions at this time. I would now like to turn the conference back to Mr. Robert Burrows.

[Bob Burrows:]

Thank you Charity. 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.

[Operator:]

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