Q3 2023 Emergent BioSolutions Inc Earnings Call
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Good afternoon, everyone I'm Jeffrey for today's call.
Thank you for joining today as emergence discusses the operational and financial results for the third quarter of 2023.
As is customary today's call is open to all participants in the call is being recorded and is copyrighted by emergent by solutions.
In addition to today's press release, there was a series of slides.
This webcast a builder to all webcast participants attending.
Turning to slides three and four during today's call emerging may make projections and other forward looking statements related to their business future events.
So first of all 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 immersion does not undertake to update any forward looking statement to reflect new information events or circumstances.
Investors should consider discretionary Steve Madden as well as the risk factors identified in emergence periodic reports filed with the S. E C. When evaluating our forward looking statements.
During today's call emerging May also discuss certain non-GAAP financial measures then Bob 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 and in the slides regarding our use of adjusted net income and loss adjusted EBITDA and adjusted gross margin and a reconciliation between emergence GAAP financial measures and these non-GAAP financial measures.
Turning to slide five day agenda for today's call will include Haywood Miller interim Chief Executive Officer, who will comment on the current state of the company.
Paul Williams, SVP and head of the products business will provide brief remarks on narcan nasal spray.
And finally, which lindahl EVP and Chief Financial Officer, who will speak to the financials for Q3, 2023 and then pivot to emotions revised forecast for full year 2023 as well as Q4 2023 total revenues.
This will be followed by Q&A session, where additional members of the executive leadership team.
And available as needed.
Finally, and for the benefit of those who may be listening to the replay of this webcast.
This call was held and recorded on November eight 2023.
Since then emergent may have made announcements related to topics discussed during today's call.
And with that I would now like to turn the call over to Hey, with Miller Haywood.
Good afternoon, everybody and thank you for joining us today.
My comments this afternoon begin on slide seven.
After my remarks, rich will detail, our third quarter performance and provide updated guidance for 2023.
I've also asked Paul Williams, Senior Vice President and head of our products business to join us to provide additional detail on the broad availability of narcan nasal spray as we continue to battle the ongoing opioid crisis.
With a full quarter of emergent now under my belt I remain encouraged by the progress we're making to improve performance we are strengthening our fundamentals and we are.
We're continuing to advance our core products business, we are focused on delivering value through our lifesaving products and shaping emergent to return to growth as we continue to further advance public health and preparedness.
Over the past few months we've.
We've made strategic and operational adjustments to strengthen emergence financial position and rightsize our business. We are prioritizing our core products and have aligned our operations with our medical countermeasures customers, namely the U S government.
We continued to achieve important milestones across our businesses, including key contract awards that reinforced the value of our products as an essential part of the government's preparedness planning.
Let me walk through some of the progress, we're making across our core products and additional achievements throughout the quarter.
First a brief update on narcan nasal spray.
At the end of August we officially launched Narcan nasal spray as an over the counter opioid overdose reversal treatment.
This is an important milestone for our company that expands access to naloxone as we seek to help save more lives and fight against the devastating opioid crisis in America.
Political support and expansion of funding avenues remains strong to address the public health crisis.
We continue to maintain a market leading position and have expanded our addressable market through the introduction of over the counter availabilities.
As a result, we expect narcan nasal spray to remain a strong contributor to revenue in the near to medium term Paul will speak more about this in a moment.
Now I'll turn to our medical countermeasures business in response to changes in the volume of U S government procurements of medical countermeasures, we are delivering on our commitments across our smallpox franchise anthrax and other products.
As demonstrated by our deliveries of the <unk> 2000, this year, our partnership with the U S government remains strong.
Also just yesterday, we announced the submission of our supplemental biologics license application to the U S food and drug administration.
Seeking approval for the expansion of the indication for <unk> 2000 to include immunization against impacts virus.
This milestone is an example of how do we evolve our existing product pipeline to address current public health threats.
We continue to operate under our current contract for the advanced development and delivery of site vendors, our anthrax vaccine.
While we work on to transition future procurement to see SNS.
We expect this year's remaining procurement to occur by year end. However, it's possible delivery may shift into next year.
Rich will cover the impact on our guidance.
As we look ahead, we will continue to service our long term USG contracts and meet the needs of our international customers.
We've also made significant progress on our sustained efforts to strengthen our quality and compliance across our manufacturing network and our enterprise.
At this point, we are moving forward with our efforts from remediation to sustaining our high standard of compliance.
As we focus on delivering for the needs of our customers.
We've had successful inspections at multiple sites by regulators.
In addition, with respect to our Camden facility in Baltimore following a reinspection in July August of 2023, we received notification from the FDA that we have addressed the matters contained in their August 22 warning letter.
FDA has also communicated that both the inspections that began in February 2022, and July August of 2023 are considered closed.
As we have shared on prior calls significant investments were made to upgrade our physical capabilities and further strengthen our culture of quality and compliance across the manufacturing network and enterprise.
Allowing us to close this action expeditiously.
Finally, we are taking steps to streamline our cost structure and deemphasize the growth of our CMO business, which we expect will strengthen our financial position in the coming quarters.
As we discussed last quarter, the strategic actions and cost reduction initiatives already underway are expected to result in annualized savings of over $100 million when fully implemented next year.
Before I turn the call over to Paul I'd like to mention that we've enhanced our board with two new independent directors, Neal Fowler and Don to Golar here.
He brings several decades of combined biopharmaceutical industry experience and has held multiple C suite positions.
Including a ceos throughout their careers, we look forward to benefiting from their unique and extensive industry expertise.
With that I will now turn the call over to Paul.
Thanks, Dave and Hello, everybody.
It was noted in his remarks, the opioid epidemic continues to worsen in the need for Narcan is growing as a result, we are seeing increased demand for narcan nasal spray in both our U S public interest channel on Canada.
But our official launch of Narcan nasal spray as an over the counter treatment in September we have delivered on our commitment to <unk> and make it available both online and on retail shelves.
Now able to offer marken on all fronts from the most vulnerable populations via the U S public interest throttle and via the retail channel over the cloud treatment, but anyone can access without a prescription to help give someone another chance.
Overdose emergency.
In September we saw hundreds of thousands of boxes to over 32000 locations, including major pharmacy retailers and e-commerce sites.
While it's possible the backlog was critical.
The broadened awareness.
The merchant proudly launched our ready to rescue National public awareness campaign in October.
<unk> aims to break down the stigma associated with opioid overdose and educate the public particularly college age adults around the risk associated with opioids will probably be prepared with narcan nasal spray.
There was on the Montney for Nokia, we are seeing continued bipartisan support to address the opioid crisis and many prominent public figures have been vocal around the importance of acquiring naloxone.
We have ongoing engagements with Oems across government retail and advocacy groups to increase access and availability of naloxone as well as educate the public on the roof of opioid overdoses of a real world needs to be prepared with narcan nasal spray.
Over the counter launches are critical advancement of our efforts to expand access increase awareness and fulfill our mission to protect and enhance lives.
Having more lives with markdown.
With the backdrop of all this we continue to be well prepared from a manufacturing and supply standpoint to meet the anticipated demand.
With that I'll turn it over to rich.
Thank you Paul and good afternoon, everyone. We appreciate you joining the call.
I'll begin by providing some context for our decision to reschedule today's earnings release and conference call.
You will note that in our press release, we reported Ltd third quarter and year to date results as well as selected balance sheet and cash flow information.
As part of our quarterly review process. The company determined that it state deferred tax liability was overstated as of December 31, 2022, resulting in an understatement of the income tax benefits reflected on the company's income statement.
While these noncash items do not have any impact on the company's liquidity cash flow historical management compensation or covenant compliance. We have concluded that it is appropriate to delay the disclosure a full third quarter and year to date earnings information and the filing of our quarterly report on Form 10-Q for the period.
Ended September 32023, while we work to correct our prior period financial statements.
We expect to complete this work in the near future and accordingly are sharing as much information as we can at this time regarding our current results and financial position.
With that I'll move to slide nine and open my remarks with the key messages I'd like you to take away from our call.
During Q3, we continued to make progress strengthening the fundamentals of the business.
As we announced in August our key focus going forward will be on the medical countermeasure and narcan businesses, while maintaining key commitments to our <unk> customers.
There were several highlights in the quarter as you've just heard from Haywood and Paul Narcan OTC hit retail shelves in September and we are excited about the opportunity to expand access to this critical opioid overdose treatment to all individuals.
The overall Narcan business had strong sales led by the public interest and Canadian channels.
And medical countermeasures procurement was in line with our expectations for Q3.
First shipment of the FDA approved <unk> was completed in September and the smallpox franchise also had positive sales primarily driven by <unk>.
Our decision to deemphasize CD amount and focus on our existing customers supported cost reduction efforts in the third quarter.
As previously disclosed we expect the full annualized run rate of these actions will exceed $100 million of reduce costs across the organization beginning in the first quarter of 2024.
Overall, we had strong revenue in the quarter, which exceeded our guidance range.
Adjusted EBITDA was also solid in the quarter slightly exceeding our expectations.
I'd like to take a moment to highlight that our Camden facility warning letter was closed out by the FDA. After acknowledgment of the extensive remediation efforts completed since August 2022.
This positive development is a testament to the dedication and skill of our quality and operations teams and positions the facility to return to normal operations as we support our existing customers going forward.
We've updated our 2023 guidance to reflect our expectations for the rest of this year a.
A key driver is the continued momentum in Narcan sales as our public interest Canadian and now retail over the counter customers seek increased preparedness for the threat of opioid overdoses.
On the medical countermeasure side, our sales forecast remains largely intact with some uncertainty regarding the timing of U S government funding for the remaining 2023 <unk> procurement as a result, we are widening our guidance ranges.
With those key updates, let's now turn to the numbers.
As indicated on slides 10, and 11 highlights in the third quarter include total revenues of $271 million, primarily driven by Narcan momentum from the U S public interest market the retail market in Canada, and the launch of Narcan, OTC and adjusted EBITDA of $20 million.
Diving deeper into the quarterly revenues important items include anthrax, MCM sales of $33 million, including deliveries of bio fracs insight as to the U S government strategic national stockpile.
Narcan sales of $142 million, demonstrating the continued strength and durability of this product driven by consistent demand from the U S public interest channel and the growing market in Canada.
Revenue in the quarter also includes initial contributions from the launch of Narcan OTC into retail channels.
Smallpox MCM sales were $25 million other.
Other product sales were $50 million, including solid back sales.
And combined CD, most service and lease revenues of $14 million reflects our continued transition to focus on existing customers.
Turning to operating expenses cost of product sales in the quarter was $133 million driven by sales of Narcan anthrax and back.
Cost of CMO of $44 million reflects reduced production across the <unk> network and the actions taken on August 8th to reduce expenses offset by investments in quality improvement initiatives at the Cameron site.
R&D expense was $15 million in SG&A expense was $86 million, including expenses supporting key narcan initiatives.
We also incurred a $218 million noncash goodwill impairment charge in the quarter related to medical countermeasures.
The impairment was primarily a result of higher interest rates and our lower market capitalization overall.
Overall, we continue to see long term value in this area of the business.
With that let's move to slide 12, and review segment performance during the quarter.
In the product segment revenues were $250 million, driven by Narcan anthrax and back and adjusted gross margin was $121 million or 49%.
As for the services segment revenues were $14 million and adjusted gross margin was negative $22 million.
Moving on to slide 13, I'll touch on select balance sheet and cash flow highlights. We ended the third quarter with $88 million in cash and $176 million of total liquidity, including availability under our revolving credit facility.
Total liquidity increased $40 million in cash was roughly flat versus the second quarter of 2023.
This reflects the collection of accounts receivable offset by debt repayments made in connection with the requirements of the May 2023 Amendment to our senior secured credit facility.
Operating cash flow was positive in the quarter and capital expenditures in the period were $13 million.
And as of September 32023, our net debt position was $779 million.
I'll now recap some of the progress we've made on our capital structure this year.
Throughout 2023, we've taken significant steps to strengthen our financial position and de risk. The business. We have executed the travel health divestiture implemented actions to save over $160 million of annualized operating expense and announced a strategic shift to deemphasize, our CMO business as a source of growth we.
Also amended and extended the maturity of our secured credit facility to May 2025.
At the same time, we've achieved positive milestones in our core products business, including the receipt of about $250 million of U S government orders for <unk> big and that the FDA approvals of <unk> and Narcan OTC.
New long term contracts for <unk>, <unk> and the ongoing growth of Narcan.
In short our core business operations are fundamentally sound and healthy.
Over the near to medium term, we will maintain our focus on optimizing our platform to further strengthen our business and credit profile and we are confident that our access to capital will improve as a result.
We will keep you informed as we make progress on this journey.
Turning to guidance, please see slide 14.
As announced in our press release. This evening, we are updating our guidance for full year 2023 as follows.
Total revenues up 1% to $1 1 billion.
Consistent with prior guidance as the ongoing strength of Narcan is offset by potential funding timing related to the remaining 2023 procurement of the FDA approved <unk> product.
We're forecasting anthrax MCM sales up 145 million to $250 million a wider range than our prior guidance given the timing uncertainty, we just discussed related to the remaining 2023 psychiatrist procurement.
While our conversations to date are aligned to funding before the end of the quarter with deliveries by year end.
We're unable to have absolute confidence in this timing given the status of the U S government's continuing resolution.
We're forecasting narcan nasal spray sales of $480 million to $490 million, an increase of $50 million at the midpoint over the prior guidance, primarily reflecting robust demand from the U S public interest channel, Canada, and the launch of Narcan OTC in September 2023.
We expect smallpox MCM sales of $180 million to $185 million, a reduction of $8 million at the midpoint from the prior guidance. The reduction reflects a timing shift of international sales for the remainder of 2023.
We expect other product sales of $100 million to $110 million, a reduction of $5 million at the midpoint from prior guidance, primarily primarily reflecting a slight reduction in revenue expectations for RFP out.
We're forecasting <unk> revenue of $70 to $75 million, which is within our previous range.
Shifting to profitability metrics, we are forecasting adjusted EBITDA of between negative $25 million to positive $75 million, a decrease of $50 million at the midpoint from the prior guidance range.
This range reflects the potential funding timing for the remaining 2023 tenders procurement as well as potential onetime costs.
And finally, we're forecasting adjusted gross margin of 32% to 38% a reduction of 250 basis points at the midpoint from the prior guidance range to.
To conclude please turn to slide 15 for some summary comments.
Our results in the third quarter were strong and we delivered on a variety of important milestones.
We're continuing to progress on our initiative to strengthen our business fundamentals by focusing on our core products, serving existing <unk> customers driving profitability and improving our balance sheet.
We continue to strengthen our quality and compliance across the organization and achieved a key milestone with the warning letter close out at our Camden facility in.
In short our progress through Q3 provides a strengthened foundation for the business to build upon going forward.
That completes my prepared remarks, and I'll now turn the call over to Heyward for closing remarks.
Thank you rich.
We look forward to answering your questions in a moment, but first I want to reiterate our go forward priorities.
We're continuing to strengthen emergence financial position and our operations by aligning to demand and capitalizing on opportunities in our products business.
We are focused on delivering quality products, including narcan nasal spray and maintaining the manufacturing standards necessary to be a leader in the MCM business.
And finally, we are positioning emergent for strategic future growth by preserving our unique capabilities to help protect and enhance life.
By focus on these three priorities, we are becoming a more agile organization.
That can manage across market cycles, and support a broad range of customers.
Over the past 25 years emergent has never lost focus on its mission or its people and that is one of the many reasons why I am confident in its ability to drive value for all of our stakeholders and importantly continue protecting enhancing life.
Now I will turn the call over to the operator for the Q&A session operator.
Ladies and gentlemen, if you'd like to ask a question at this time, you will need to press star one on one on you touched on.
So with a question. Please press star one again.
Please standby, while we compile the Q&A roster.
Yeah.
And I'm sure we have a question.
From the line of Forest Speaker with TD Cowen Your line is now open.
Great. Thanks, This is Nick on for Boris.
One for me on Narcan can you speak a little bit more to the uptick in the public interest market in Canada, I know that last quarter, you said that you've seen an increase there in this quarter you said that it's been strong have you also seen an increase there.
And then also on the OTC launch what are you seeing on that and are you seeing an increase in the retail space.
A little bit more granularity on Narcan revenue would be great. Thanks.
Alright. Thanks.
Yep.
Paul on the line and so I think Paul those are good questions for you to take on.
Well Nick Thanks for the question I think TD the propane call. The question I think the most important thing I think at the very top.
A crisis continues to worsen.
<unk> Dot promos is growing this year I think this has really led to the increase need and demand for narcan at the state and local level through the <unk> channel and recognizing that these organizations are at the front lines of the opioid crisis.
In a similar fashion, we're seeing similar trends happening in Canada as well as they look to allocate more funding on the book you I'll step in Canada to address sort of what's happening at the sort of the frontline.
Frontline level with the crisis.
To your question around the ATC lots I think we are a really good spot.
Six weeks into the launch I think where we were able to ship.
All of our retail customers and online customers e-commerce customers that.
But we expect the team.
This is a new channel for us.
As much as expanding access is critical to for folks to be able to access it on the shelf for online awareness piece is equally as critical and so the launch of the ready to rescue campaign on top of offering narcan in the retail setting.
Right now is really in line with what our expectations would be the first phase of the launch.
Got it that's helpful and just a follow up on that I know, it's still early into the launch of course.
But I know that you mentioned at least when you first launched the OTC Narcan that you shipped out.
The doses are you planning to do it in a similar fashion, while youll be shipping out thousands of doses or will it be at a bar is like an ad.
As needed basis to a different retailers at least for retail E Commerce I'm curious.
Yes, I think initially we wanted to make sure that all of our partners, we're adequately staffed to meet demand.
And I think as <unk>.
<unk> continues to grow will replenish that demand relative to what those individual retailers and e-commerce sites need in terms of what they want to keep in terms of what the run rate continues to move in <unk>.
Great. Thanks very much.
Thank you.
And our next question coming from the lineup.
Frank Dilorenzo with singular research your line is now open.
Good afternoon. Thanks for taking my call I had a couple of questions around the updated guidance one was related to the anthrax business.
And the lower guidance.
The difference in the previous Sky guidance incurred will some of that be made up into 2024 is that a timing issue on procurement et cetera.
Separate from that can you give us a little more granularity on the.
Adjusted gross margin guidance whats pressure.
Pressuring that they're in but subside into 2024. Thank you.
Yes, Frank Thanks, Thanks for the question.
As far as the anthrax guidance is concerned as we as we mentioned the guidance at the high end contemplates the receipt of the of the next quarter for 2023 procurement.
As we indicated we're all aligned towards having that be received in time for the deliveries by the end of the year, but just given the current situation in Congress with the continuing resolution there is some uncertainty about whether or not that could slip out of this year and into next year. So that's the way to think about that.
As far as the adjusted gross margin and Thats really just.
A mix element in terms of the overall product mix reflected by the revised guidance.
And.
Some other onetime costs that have come into play throughout the course of the year.
Thanks.
One other question. This time on the Narcan business can you talk about maybe some non traditional markets if you're seeing any movement. There is potential for some penetration into areas such as.
It may be more industrial corporate penetration first aid kits things like that thank you.
Paul you want to take that one yeah.
Yes happy to so while our initial launch was primarily geared towards the retail pharmacy.
And E Commerce sites, obviously, though.
Call it the business the business segments.
It was obviously a key area for us and we're looking to I think launch into that segment.
In the beginning of the year, but we're in active conversations with.
Multiple stakeholders across the <unk> segment.
We're defining it.
Okay. Thank you.
Thank you.
And thank you with that.
Ladies and gentlemen, we now conclude the call. Thank you for your participation. Please note an archived version of today's webcast.
PDF version of the slides used during todays call will be available later today and accessible through the investor lending page on the company website.
Thank you again, we look forward to speaking with you on the feature Goodbye.
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