Q4 2023 Emergent BioSolutions Inc Earnings Call
Operator: www.theFNDC.com Department of Land, Land Use, and Good afternoon, everyone. I'm the operator for today's call. Thank you for joining us today as Emergent discusses its operations and financial results for the fourth quarter and full year. 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 slide three, during today's call, Emergent may make projections and other forward-looking statements related to its business, future events, its prospects, or future performance. These forward-looking statements are based on their current intentions, beliefs, and expectations regarding future events. Any forward-looking statement speaks only as of today of this conference call. And, as expected or required by law, Emergent does not undertake to update any forward-looking statement to reflect new information, events, or circumstances.
Yeah.
Good afternoon, everyone I'm the operator for today's call. Thank you for joining today as a merchant discusses their operation and financial results for the fourth quarter and full year as is customary today's call is open to all participants in the call is being recorded and is copyrighted by emergent bias.
Solutions. In addition to today's press release, there is a series of slides accompanying this webcast available to all webcast participants turning to slide three during today's call emergent may make projections and other forward looking statements related to their business future events, there are prospects or.
Future performance. These forward looking statements are based on their current intentions beliefs and expectations regarding future events any forward looking statement speakers only as today of this conference call and as expected by required by law emergent does not undertake.
To update any forward looking statement to reflect new information events or circumstances investors should consider this cautionary statement as well as risk factors identified in the emergence periodic reports filed with the SEC when evaluating their forward looking statements.
Operator: Investors should consider this cautionary statement as well as risk factors identified in Emergent's periodic reports filed with the SEC when evaluating its forward-looking statements. During today's call, Emergent may also discuss certain non-GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding its operating performance. Please refer to the table found in today's press release. Turning to slide four, the agenda for today's call will include Joe Papa, President and Chief Executive Officer, who will comment on our focus and priorities. Paul Williams, SVP and Head of the Products Business, will provide comments on Narcon, Nasal Spray, and finally, Rich Lindahl, EVP and Chief Financial Officer, who will speak to the current state of the company and financials for the fourth quarter and full year and guidance for full year 2024. This will be followed by a Q&A.
Today's call emergent may also discuss certain non-GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding emergence operating performance. Please refer to the table found in today's press release, turning to slide four the agenda for today's.
Carl will include Joe Papa President and Chief Executive Officer, who will comment on our focus and priorities Paul Williams, SVP and head of the products business will provide comments on narcan nasal spray and finally, rich lindahl, EVP and Chief Financial Officer.
Who will speak to the current state of the company and financials for fourth quarter and full year guidance for full year 2024.
This will be followed by a Q&A finally and for the benefit of those who may be listening.
Operator: Finally, and for the benefit of those who may be listening, To the replay of this webcast, this call was held and recorded on March 6th and 6th, 2024. Since then, Emergent may have made announcements related to topics discussed during today's call. And with that, I would like to turn the call over to Rich Lindahl for opening remarks.
Two the replay of this webcast. This call was held and recorded on March 626, 2024. Since then emergent may have made announcements related to topics discussed during today's call and with that I would like to turn the call over to rich lindahl for opening remarks rich.
Richard S. Lindahl: Thank you, Jonathan. Good evening, everyone. And thank you for joining us tonight. Before we get into our results for the fourth quarter and full year, I'd like to take a moment to introduce our new President and Chief Executive Officer, Joe Papa, who joined us a few weeks ago. We are thrilled to have him on our team and look forward to benefiting from his over 35 years of experience in the healthcare and pharmaceutical industries, along with his proven record as a transformational leader. Now, I will turn it over to Joe to say a few words. Thank you, Rich, for the warm welcome. Good afternoon, everyone.
Okay.
Thank you Jonathan and good evening, everyone and thank you for joining us Tonight.
Before we get into our results for the fourth quarter and full year I'd like to take a moment to introduce our new President and Chief Executive Officer, Joe Papa who joined US a few weeks ago.
We are thrilled to have him on our team and look forward to benefiting from his over 35 years of experience in health care and pharmaceutical industry, along with his proven record as a transformational leader.
Let me turn it over to Joe to say a few words.
Thank you rich for that warm welcome and good afternoon, everyone I'm delighted to join the team and further emergent mission of protecting and enhancing the lives of patients a lot of people ask me what drew me to merchant.
Joe Papa: I'm delighted to join the team and further Emergent's mission of protecting and enhancing the lives of patients. A lot of people have asked me what drew me to Emergent. That's easy.
Joe Papa: I've always been driven by the ability of pharma to save lives, and Emergent plays a unique and critical role in addressing public health crises. As the leading biodefense contractor, we're addressing the most pressing and urgent threats. Like the opioid epidemic, where the data tells us every six minutes an American dies from an opioid overdose.
I've always been driven by the ability of farmer to save lives and emerging plays a unique and critical role in addressing public health crisis, and the leading bio defense contractor, we're addressing the most pressing and urgent threats.
The opioid epidemic, where data every six minutes and Americans die from an opiate overdose anthrax the number one bacterial infectious threat to smallpox number one viral threat to batch was most of the lethal biologics.
Joe Papa: To anthrax, the number one bacterial infectious threat. To smallpox, the number one viral threat. To botulism, the most lethal biological toxin.
Joe Papa: Ebola, a hemorrhagic fever, and chemical threats like nerve gas that have implications for our servicemen and women. Emergent has paid really is really not many can match or, in other words. We have a significant moat around our business. Also, the near-term challenges that Emergent has been facing, notably our debt, have impacted our ability to achieve our full potential. I'm eager to work with the team and tackle these challenges head-on. Based on my three decades of experience in the industry and now, knowing the determination of the Emergent board and the leadership team, I believe we can successfully navigate these issues that Emergent faces today. I'd like to bring your attention to slide number six of our presentation. While I am only two weeks into my CEO role, we will move forward with a multi-year plan to stabilize, turn around, and then transform our company. Of course, a business transformation isn't going to happen overnight.
Hemorrhagic fever.
In chemical threats like nerve gap that has implications to our service menu minute emergent has really not many can match or another words.
Significant moat around our business.
Also the near term challenges that emerged we have been facing notably our debt has impacted our ability to achieve our full potential I am eager to work with the team and tackle these challenges head on and based on my three decades of experienced industry and now knowing the determination of the merchant Board and leadership team I believe we can successfully navigate through these issues.
Use that emergent patients today I'd like to you for your attention to slide number six of our presentation well I am only two weeks into my CEO role, we will move forward with a multiyear plan to stabilize turnaround and then transform our company of course, a business transformation isn't going to happen overnight the first phase.
Joe Papa: The first phase, stabilizing Emergent, will take us three to six months and will focus on continuing to build credibility with our key stakeholders, including employees, customers, government regulators, shareholders, and debt holders. For example, that means looking to strengthen the engagement of all of our employees and focusing on our exciting mission to protect, enhance, and help save lives. Also, it is clear we must de-risk our balance sheet and reduce our debt now.
<unk> emergence, we expect will take us three to six months and will focus on continuing to build credibility with our key stakeholders, including employees customers government regulators shareholders and debt holders for example, I mean looking to strengthen the engagement of all of our employees and focusing on our exciting mission to protect and enhance.
And help save lives also is clear we must derisk our balance sheet.
Joe Papa: In that regard, today, we announced that we've entered into a forbearance agreement through April 30th, 2024 with our lenders, which will take us through this in more detail later on. The next phase, our turnaround, will begin in 2024 and will span into 2025. We'll focus on key growth opportunities and investments that will drive profitable growth by improving our operating performance, reducing our working capital, and may include product and asset divestitures. We expect these actions will be critical in our efforts to reduce our debt and de-risk our balance sheet.
Reduce our debt now in that regard today, we announced that we've entered into a forbearance agreement through April 32024, with our lenders, which will take us through this in more detail later on.
The next phase our turnaround will begin in 2020 for spirit into 'twenty to 'twenty five we'll focus on key growth opportunities and investments that will drive profitable growth by improving our operating performance reduce our working capital and may include product and our asset divestitures.
These actions will be critical in our efforts to reduce our debt and to derisk our balance sheet.
Joe Papa: Our final phase, Transformation, is planned for 2026 and beyond. We'll focus on strategically transforming Emergent to achieve durable and sustainable growth and profitability. I also want to note an important driver of Emergent's past and future success is quality and compliance. Quality and compliance are key value drivers for Emergent and will remain a top priority.
Our final phase transformation plan for 2026, and beyond we will focus on strategically transformed to achieve durable and sustainable growth and profitability.
I also want to note an important driver of margins past and future success is quality and client quality and compliance are key value drivers for merchants. It will remain a top priority our products are relied upon to save lives and a time of crisis, our patients and customers depend on us we must continue to provide the highest quality.
Joe Papa: Our products are relied upon to save lives in a time of crisis. Our patients and customers depend on us. We must continue to provide the highest quality products to ensure that customers, government agencies, and patients have confidence in us as a trusted partner. In 2023, Emergent Manufacturing Facilities were successfully inspected by five regulatory agents from around the globe and five other inspectional bodies for a total of 18 inspections, including three by the FDA that resulted in either an NAI status or VI status. This includes the successful closeout of the Baltimore Camden Warning Letter in just 14 months. That's very significant.
Alex to ensure that customers government agency patients have confidence in us as a trusted partner in 2023 emergent manufacturing facilities have been successfully inspected by five regulatory agents from around the globe and five other inspection of body for a total of 18 inspection, including three by the FDA.
That resulted either an nai status for <unk>.
This includes successful closeout of the Baltimore Camden warning letter in just 14 months, that's very significant truly remarkable accomplishment by the merchant team the leadership team their teams and the broader organization.
Joe Papa: Truly remarkable accomplishments by the Emergent team, the leadership team, their teams, and the broader organization. To this end, over my first two weeks, I've had the pleasure of meeting many of the talented and dedicated employees that work at Emergent and will continue to visit more Emergent facilities in the coming weeks. The commitment to the mission and values is so clear in each and every employee that I've met with.
It has been.
Over my first two weeks I've had the pleasure of meeting many of the talented and dedicated employees that work any merger you'll continue to get more emergent facilities in the coming weeks the commitment to the mission and values are so clear in each and every employee that I've met with I look forward to visiting with more sites in the next few weeks and speaking directly with our key members I'm confident the team insightful.
Joe Papa: I look forward to visiting more sites in the next few weeks and speaking directly with our team members. I'm confident the team's insights will enhance how we deliver value to our customers, partners, patients, and shareholders. I'm going to take that feedback from the team, setting clear goals that we can align around together as an organization, and that's what's going to drive the results. It's a privilege to lead Emergent and chart a new chapter in this vital space, whether it's increasing access to Narcan nasal spray to help combat the LPF epidemic or continuing to deliver important medical countermeasures to customers around the world. Emergent is providing critical products to address global health crises in an increasingly dangerous world. I'm confident that these important treatments will provide for a bright future, and I look forward to advancing the company's progress, improving its financial position, and driving value for shareholders. Given my two-week tenure at the company, Richard will provide an overview of the quarter. Before that, I'll turn it over to Paul to discuss Narcan Nasal Spray, our largest product, representative of the important work Emergent does for patients. Thank you, Joe, and hello, everyone.
Enhance how we deliver value to our customers partners patients and shareholders I'm going to take that feedback from the team set a clear goals that we can align around together as an organization and that's going to drive the results. It's.
Privilege to lead emergent and charter a new chapter in this vital space, whether it's increasing access to narcan nasal spray to help combat the opioid epidemic are continuing to deliver important medical countermeasures to customers around the world.
<unk> is providing critical products to address global health crisis, and an increasingly dangerous world.
Confident that these important tribute right for a bright future and I look forward to advancing the company's progress improving financial position and driving value for shareholders.
Given my two week tenure at the company, which will provide an overview of the quarter before that I will turn it over to Paul to discuss Narcan nasal spray our largest products represented the important work of Virgin does for patients.
Families and communities and will no doubt be an important value driver for the company going forward the bulk of turnkey.
Thank you, Joe and Hello, everyone.
Turning to slide eight of the presentation I'd like to start by reviewing the state of the opioid crisis.
The latest CDC data show a 105000 people sadly died from drug overdose over the latest 12 month period of which nearly eight and 10 were opioid related.
Today opioid overdose is a leading cause of accidental deaths in the U S and with the recent rise in synthetic opioids such as fentanyl.
Paul Williams: Turning to slide 8 of the presentation, I'd like to start by reviewing the state of the opioid crisis. The latest CDC data show 105,000 people sadly died from drug overdose over the latest 12-month period, of which nearly 8 in 10 were opioid-related. Today, opioid overdose is the leading cause of accidental death in the U.S., and with the recent rise in synthetic opioids such as fentanyl, we see very little sign of a bakelite. These are unsettling and staggering...
We see very little sign of abatement.
These are unsettling and staggering statistics with so many families loved ones friends and communities behind these lives lost.
Since adding narcan nasal spray to our portfolio in 2018, we continue to play a key role in responding to the devastating opioid crisis.
In this past year was filled with historic patient and customer first milestones that broad access and increased awareness of our lifesaving opioid overdose reversal treatment.
Paul Williams: So many families, loved ones, friends, and communities are behind these lives lost. Since adding Narcan nasal spray to our portfolio in 2018, we continue to play a key role in responding to the devastating opioid crisis. This past year was filled with historic, patient, and customer-first milestones that broadened access and increased awareness of our lifesaving opioid overdose reversal treatment. 2023 began with a favorable FDA Advisory Committee's unanimous vote in support of our product's OTC use and then FDA approval of that designation in March. We believe Narcan Nasal Spray should be immediately accessible alongside AED kits at businesses and workplaces, as well as in small businesses, in schools, and on airplanes, because an opioid overdose can happen to anyone, anywhere, and at any time.
2023 began with a favorable FDA advisory committees unanimous vote in support of our products OTC use and then FDA approval of that designation in March.
We believe narcan nasal spray <unk> immediately accessible alongside AED kits and businesses and workplaces as well as across small businesses and schools on airplanes.
Because an opioid overdose can happen to anyone anywhere and at any time.
Our OTC retail launch of Narcan nasal spray in August has provided access and availability across 32000 outlets spanning mass drug and grocery and online retailers and ecommerce sites and.
In 2024, we will expand access further into businesses workplaces and other channels as well as planning for the introduction of future line extensions.
In the U S public interest channel continues to grow our <unk> and proprietary distribution platform Narcan direct supports our customers' needs and helps facilitate seamless ordering and distribution of the product to the many thousands of endpoints that are critical in dispensing narcan nasal spray into the hands of those who need it.
Paul Williams: Our OTC retail launch of Narcan Nasal Spray in August has provided access and availability across 32,000 outlets spanning mass, drug, grocery, and online retailers and e-commerce sites. In 2024, we will expand access further into businesses, workplaces, and other channels, as well as planning for the introduction of future line extensions. In the U.S., the public interest channel continues to grow. Our one-of-a-kind and proprietary distribution platform, NARCAN Direct, supports our customers' needs and helps facilitate seamless ordering and distribution of the product to the many thousands of endpoints that are critical in dispensing NARCAN nasal spray into the hands of those who need it. This past year, our ability to meet increasing demand enabled us to distribute approximately 22 million doses or 11 million two-dose cartons in the U.S. and Canada to get Narcan into the hands of those who need it the most and provide a chance to save a life. And most recently, in January of this year, we announced the shelf life extension of Narcan nasal spray from 36 months to 48 months in the United States.
This past year, our ability to meet increasing demand enabled us to distribute approximately 22 million doses or $11 million kudos cartons in the U S and Canada to get dark and into the hands of those who need it the most and provide a chance to save a life.
And most recently in January of this year, we announced the shelf life extension of Narcan nasal spray from 36 months to 48 months in the United States.
This will increase adoption and access to the product.
We've also made a tremendous impact with our ready to rescue campaign, which aims to break down the stigma associated with opioid overdose and educate the public and a particular college age adults.
We continue to partner with public figures and notable influencers to expand awareness of the risks associated with opioid use and the importance of being prepared with narcan nasal spray.
In the coming quarters will continue to execute on our plans to broaden access and availability of narcan nasal spray and meet the demand as we seek to help save more lives.
Now I would like to turn it over to rich to discuss our fourth quarter performance in more detail. Thanks.
Thanks, Paul I'll begin by expanding on the 8-K filing that Joe mentioned earlier in the call.
Today, we announced that we have entered into a forbearance agreement with our lenders through April 30th while we continue our initiatives to increase operational performance improved working capital and pursue certain product or asset sales.
Richard S. Lindahl: We believe this will increase adoption and access to the product. We've also made a tremendous impact with our Ready to Rescue campaign, which aims to break down the stigma associated with opioid overdose and educate the public, and in particular college-age adults. We continue to partner with public figures and notable influencers to expand awareness of the risks associated with opioid use and the importance of being prepared with Narcan nasal spray. In the coming quarters, we'll continue to execute on our plans to broaden access to and availability of Narcan nasal spray and meet demand as we seek to help save more lives. Now, I'd like to turn it over to Rich to discuss the fourth quarter performance in more detail. Thanks, Paul.
As Joe highlighted the transformation of the company will be a multiyear process with the near term being heavily focused on strengthening our credit profile and capital structure all.
All decisions will be made through the lens of improving overall performance and enhancing enterprise value.
While the details of the sale processes are confidential, we seek to generate additional cash proceeds that can be used to further reduce our debt and enable credit improvement as we transform the business. The forbearance agreement provides further evidence of a constructive relationship. We continue to have with our lenders and we look forward to providing further updates on our capital structure in the fee.
Sure.
During the fourth quarter emergent made great progress improving the fundamentals of our business and advancing our core products, we continue to reduce costs and rightsize operations in order to Derisk, the business and strengthen our financial position.
Richard S. Lindahl: I'll begin by expanding on the 8k filing that Joe mentioned earlier in the call. Today, we announce that we have entered into a forbearance agreement with our lenders through April 30th, while we continue our initiatives to increase operational performance, improve working capital, and pursue certain products or assets. As Joe highlighted, the transformation of the company will be a multi-year process, with the near term being heavily focused on strengthening our credit profile and capital structure. All decisions will be made through the lens of improving overall performance and enhancing enterprise value.
These actions reflect our sharpen strategic focus and the ongoing transformation of our business as we concentrate on enhancing revenue improving operational efficiencies and reducing debt.
Throughout 2023, we maintained a very positive relationship with the U S government and other key medical countermeasure customers.
As a result, we achieved significant contract awards that reinforce the value of our products as in a central part of the government's preparedness planning, which continues to evolve.
Richard S. Lindahl: While the details of the sale processes are confidential, we seek to generate additional cash proceeds that can be used to further reduce our debt and enable credit improvement as we transform the business. The Forbearance Agreement provides further evidence of the constructive relationship we continue to have with our lenders, and we look forward to providing further updates on our capital structure in the future. During the fourth quarter, Emergent made great progress improving the fundamentals of our business and advancing our core products. We continue to reduce costs and right-size operations in order to de-risk the business and strengthen our financial position. These actions reflect our sharp and strategic focus and the ongoing transformation of our business as we concentrate on enhancing revenue, improving operational efficiencies, and reducing debt.
Having said that as I will expand on in a few minutes. Our 2024 forecast has more variability than in years past.
In October we appointed two pharmaceutical industry veterans to the board Neal Fowler and Don Dakota here, who bring more than 70 years of combined biopharmaceutical industry and sales experience.
We believe their expertise will be valuable as we continue to grow Narcan sales advanced our other products and partner with government to prepare for public health threats.
Let me walk through some of the progress, we're making across our core product as highlighted on slide 10 as.
As you just heard from Paul after many years of research and development and in partnership with the FDA, We officially launched Narcan nasal spray as an over the counter opioid overdose reversal treatment in August last year.
This is a monumental milestone for our company and expanded access to naloxone.
About the year, we've been able to meet the ever increasing demand for narcan, resulting in expanded access and broader awareness of narcan and underpinned by strong support from federal and state programs.
Richard S. Lindahl: Throughout 2023, we maintained a very positive relationship with the U.S. government and other key medical countermeasure customers. As a result, we achieved significant contract awards that reinforced the value of our products as an essential part of the government's preparedness planning, which continues to evolve. Having said that, as I'll expand on in a few minutes, our 2024 forecast has more variability than in years past. In October, we appointed two pharmaceutical industry veterans to the board, Neil Fowler and Don DeGoyer, who bring more than 70 years of combined biopharmaceutical industry and sales experience.
As we look ahead, we expect narcan nasal spray to remain a key contributor to our growth in the near term.
We also secured several important contract wins last year across our other core products, including a new $379 6 million dollar U S Department of defense defense contract for RTL.
A $75 million option to extend emergence existing contract for site fitness.
And a 10 year contract with BARDA valued at $704 million for the development and manufacturing scale up their procurement.
<unk> our license treatment for Ebola virus.
And we've already announced a contract award for 2024 with the U S Department of defense valued at $235 8 million to.
To supply <unk>, a form of anthrax vaccine.
This new contract award is a testament to the importance of our medical countermeasure portfolio to the U S government's preparedness and response plans.
Richard S. Lindahl: We believe their expertise will be valuable as we continue to grow Narcan sales, advance our other products, and partner with governments to prepare for public health threats. Let me walk through some of the progress we're making across our core products, as highlighted on slide 10. As you just heard from Paul, after many years of research and development and in partnership with the FDA, we officially launched Narcan nasal spray as an over-the-counter opioid overdose reversal treatment in August last year.
Finally, we achieved many important R&D milestones. This year in July 2023, we received U S. FDA approval of <unk>, a two dose anthrax vaccine for post exposure prophylaxis use.
We received health, Canada regulatory approvals for our AGM 2000 vaccine and come back to the drug that each address smallpox. We also submitted a supplemental BLA to the FDA that would extend the ATM to thousands indication to include immunization against the inbox filings.
Richard S. Lindahl: This is a monumental milestone for our company that expanded access to Naloxone. Throughout the year, we've been able to meet the ever-increasing demand for NARCAN, resulting in expanded access and broader awareness of NARCAN, and underpinned by strong support from federal and state programs. As we look ahead, we expect Narcan nasal spray to remain a key contributor to our growth in the near term.
We expect to hear back from the FDA by the third quarter of this year.
These contracts and development advances reflect the U S governments need to maintain a high level of preparedness against a wide range of potential threats that frankly are increasing as events unfold worldwide <unk>.
Merchant is uniquely positioned to deliver these products and an efficient and cost effective manner and we are committed to supporting the U S government's efforts to address emerging infectious diseases and strengthen future preparedness.
Richard S. Lindahl: We also secured several important contract wins last year across our other core products, including a new $379.6 million U.S. Department of Defense contract for RCL, a $75 million option to extend Emergent's existing contract for Sipendis, and a 10-year contract with BARDA valued at $704 million for the development and manufacturing scale-up and procurement of Evanga, our licensed treatment for the Ebola virus. And we've already announced a contract award for 2024 with the U.S. Department of Defense, valued at $235.8 million, to supply BioFrax, a form of the anthrax vaccine. This new contract award is a testament to the importance of our medical countermeasure portfolio to the U.S. government's preparedness and response. Finally, we achieved many important R&D milestones this year. In July 2023, we received U.S. FDA approval of Stipendis, a two-dose anthrax vaccine for post-exposure prophylactic use.
In 2023, we also completed several initiatives to improve our credit profile and Derisk our capital structure.
As you know, we divested our travel health business generating up to $380 million of proceeds extended the maturity of our secured credit facility to May 2025 implemented actions to save over $160 million of annualized operating expense and announced a strategic shift to focus on our products business.
Turning to our results we had solid revenue in the quarter, which led to full year 2023 revenue in line with the midpoint of our guidance range provided on November eight adjust.
Adjusted EBITDA was impacted by revenue timing and one time write offs, which I'll provide further detail on shortly.
As indicated on slide 11 highlights in the fourth quarter include total revenues of $277 million driven by Narcan and SIFI Miss.
Total segment adjusted gross margin of $86 million.
Adjusted EBITDA in the quarter of $3 $4 million and adjusted net loss of negative $40 million.
Diving deeper into the quarterly revenues important items on slide 12 include anthrax MCM sales at $112 million driven by select vendors deliveries to the U S government strategic national stockpile, including initial shipments under the $75 million contract option provided by BARDA that we announced on November 28.
Richard S. Lindahl: We received Health Canada regulatory approvals for our ACAM2000 vaccine and Timbexa drug that each address smallpox. We also submitted a supplemental BLA to the FDA that would extend ACAM2000's indication to include immunization against the mumps virus. We expect to hear back from the FDA by the third quarter of this year. These contracts and development advances reflect the U.S. government's need to maintain a high level of preparedness against a wide range of potential threats that are, frankly, increasing as events unfold worldwide. Emergent is uniquely positioned to deliver these products in an efficient and cost-effective manner, and we are committed to supporting the U.S. government's efforts to address emerging infectious diseases and strengthen future preparedness. In 2023, we also completed several initiatives to improve our credit profile and de-risk our capital structure.
Narcan sales of $111 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 contributions from the launch of OTC narcan into retail channels.
Smallpox MCM sales of $12 million driven by the <unk> IV.
Other product sales of $15 million, primarily related to <unk> and.
In total bio services revenues of $21 million, reflecting our continued transition to focus on existing customers.
Turning to operating expenses on slide 13 cost of commercial product sales in the quarter was $50 million driven by strong sales of Narcan.
Cost of MCM product sales in the quarter was $97 million driven primarily by <unk> sales volume and other medical countermeasure products as well as an increased inventory write offs.
Cost of bio services of $38 million, reflecting actions taken to improve profitability.
R&D expense of $29 million, which includes onetime costs associated with project terminations and SG&A spend of $90 million, including expenses supporting key narcan initiatives reduced by expenses offset by reduced expenses related to restructuring initiatives.
Richard S. Lindahl: As you know, we divested our travel health business, generating up to $380 million in proceeds, extended the maturity of our secure credit facility to May 2025, implemented actions to save over $160 million in annualized operating expenses, and announced a strategic shift to focus on our products. Turning to our results, we had solid revenue in the quarter, which led to full year 2023 revenue in line with the midpoint of our guidance range provided on November 8. Adjusted EBITDA was impacted by revenue timing and one-time write-offs, which I'll provide further detail on shortly.
With that let's move to slide 14, and review segment performance during the quarter.
Note that beginning with the fourth quarter of 2023, we now report our results in three segments commercial products <unk> products and services. This change will provide increased transparency for investors as we move forward.
In the commercial segment revenues were $111 million comprised entirely of Narcan and segment adjusted gross margin was $61 million or 55%.
In the Mcs segment revenues were $138 million, driven by anthrax, our STL and back to <unk>.
Richard S. Lindahl: As indicated on slide 11, highlights in the fourth quarter include total revenues of $277 million, driven by Narcan and Sipendex; total Segment Adjusted Gross Margin of $86 million; adjusted EBITDA in the quarter of $3.4 million, and adjusted net loss of negative $40 million.
Segment, adjusted gross margin was $42 million or 30%.
As for the services segment revenues were $21 million and segment adjusted gross margin was negative $17 million.
Shifting to slide 15, I'll highlight our 2023 full year performance.
Full year revenue was $1 5 billion in line with the midpoint of our previously provided guidance full.
Richard S. Lindahl: Diving deeper into the quarterly revenues, important items on slide 12 include ANPRAC's MCM sales of $112 million, driven by stipendiously deliveries to the U.S. government's Strategic National Stockpile, including initial shipments under the $75 million contract option provided by BARDA that we announced on November 28th, and NARCAM's sales of $111 million, demonstrating the continued strength and durability of this product driven by consistent demand Revenue in the quarter also includes contributions from the launch of OTC Narcan into retail channels. Smallpox MCM sales of $12 million were driven by VIGID.
Full year total segment adjusted gross margin was $336 million or 33% at the low end of our guidance range.
Full year adjusted EBITDA was negative $22 million also at the low end of our range.
And adjusted net loss was negative $319 million.
Transitioning to slide 16, I will highlight the 2023 full year costs.
Cost of commercial products was $210 million driven by the continued strength of narcan nasal spray in the existing channels as well as the launch of Narcan nasal spray over the counter in late August 2023.
Cost of MCM products was $306 million.
Which was influenced by sales volume product mix and Unabsorbed manufacturing overhead costs.
Cost of bio services was $190 million heavily influenced by our cost structure in the first half of 2023, which was a primary focus of the cost reduction actions, we announced on August eight.
Richard S. Lindahl: Other product sales of $15 million, primarily related to RSDL and BAS, and Total Bioservices revenues of $21 million, reflecting our continued transition to focus on existing customers. Turning to operating expenses on slide 13, the cost of commercial product sales in the quarter was $50 million, driven by strong sales of Narcan. The cost of MCM product sales in the quarter was $97 million, driven primarily by syphilis sales volume and other medical countermeasure products, as well as an increased inventory write-off.
R&D expense was $97 million, including the chikungunya costs prior to the divestiture of the travel health business.
SG&A was $368 million, which included additional marketing expenses related to narcan legal fees and restructuring expenses.
Moving to slide 17, commercial product segment revenue for the full year was $497 million up roughly $100 million versus the prior year with a segment adjusted gross margin of 58% in line with the prior year and reflecting pricing reductions, we took mid year on narcan nasal spray to improve access and affordability.
Richard S. Lindahl: The cost of bioservices of $38 million, reflecting actions taken to improve profitability, is in the expense of $29 million, which includes one-time costs associated with project termination, and SG&A spend of $90 million, including expenses supporting key NARCAN initiatives, offset by reduced expenses related to restructuring. With that, let's move to slide 14 and review segment performance during the quarter. Note that beginning with the fourth quarter of 2023, we will now report our results in three segments, commercial products, MCM products, and services. This change will provide increased transparency for investors as we move forward. In the commercial segment, revenues were $111 million, comprised entirely of Narcan, and segment adjusted gross margin was $61 million, or 55%. In the MCM segment, revenues were $138 million, driven by Antfrax, RSDL, and BAT; segment adjusted gross margin was $42 million, or 30%. As for the services segment, revenues were $21 million, and the segment adjusted gross margin was negative $17 million.
Full year MCM products segment revenue was $447 million and segment adjusted gross margin was 34% the.
The margin for the MCM business was influenced by sales volume product mix cost absorption and inventory write offs.
In the services segment had revenue of $79 million and segment adjusted gross margin of negative $130 million.
Influenced by sales volumes and costs in the first half of 2023 prior to our restructuring efforts announced on August eight.
I'll now turn to slide 18, and touch on select balance sheet and cash flow highlights.
We ended 2023 with $112 million in cash and $192 million of total liquidity, including availability under our revolving credit facility.
The increase in cash and liquidity versus the prior quarter was due to sales timing and collection of accounts receivable.
Operating cash flow on a full year with negative but in the second half of 2023, it was positive $92 million.
Capital expenditures were $52 million in 2023 and as of December 31, our net debt position was $757 million.
Turning to 2024 guidance, please see slide 19.
As announced in our press release. This evening, we are providing guidance for full year 2024 as follows total revenues of $900 million to $1 $1 billion.
Commercial product sales of $460 million to $500 million as.
Richard S. Lindahl: Shifting to slide 15, I'll highlight our 2023 full year performance. Four-year revenue was $1.05 billion, in line with the midpoint of our previously provided guide. Full Year Total Segment Adjusted Gross Margin was $336 million, or 33% at the low end of our guidance. Full Year Adjusted EBITDA was negative $22 million, also at the low end of our range, and Adjusted Net Loss was negative $319
As we expect continued strong demand for Narcan in the U S public interest channel in Canada, combined with further growth with OTC narcan in the retail channel.
We're forecasting MCM product sales of $340 million to $490 million.
As we've previously noted <unk> is a fully licensed the primary procurement will transition from BARDA to the strategic national stockpile.
We recognize that the U S government is balancing multiple threat preparedness needs with the level of funding provided by Congress and at this fact that impact the magnitude and timing of any particular anthrax procurements in the near term even if this potential threat remains a top strategic priority.
Richard S. Lindahl: Transitioning to slide 16, I'll highlight the 2023 four-year cost. The cost of commercial products was $210 million, driven by the continued strength of Narcan nasal spray in the existing channels, as well as the launch of Narcan nasal spray over-the-counter in late August 2023. The cost of MCM products was $306 million, which was influenced by sales volume, product mix, and unobserved manufacturing overhead costs. The cost of bioservices was $190 million, heavily influenced by our cost structure in the first half of 2022, which was a primary focus of the cost reduction actions we announced on August 8. R&D expenses were $97 million, including the chikungunya costs prior to the divestiture of the travel home business.
As a result, we've provided a wide range of potential outcomes for the Mcs segment.
We continue to engage with our U S government stakeholders to improve the procurement visibility that is needed to support this critical capability for the benefit of all United States citizens.
As a final note on the MCU products, we continue to see stable consistent sales to the U S government under the long term contracts, we have in place for our plasma and chemical decontamination products <unk>.
Back in <unk>.
We're forecasting services segment revenue of $70 million to $80 million, reflecting our commitment to serving our existing customers.
Shifting to profitability metrics, we are forecasting adjusted EBITDA of $50 million to $100 million.
Reflecting the impact of our 2023 cost reduction actions are capacity utilization profile and a range of revenue expectations across our segments.
Richard S. Lindahl: SG&A was $368 million, which included additional marketing expenses related to NARCAN, legal fees, and restructuring. Moving up to slide 17, commercial product segment revenue for the full year was $497 million, up roughly $100 million versus the prior year, with a segment-adjusted gross margin of 58 percent, in line with the prior year and reflecting pricing reductions we took mid-year on Narcan nasal spray to improve access and affordability. Full year MCM product segment revenue was $447 million, and segment adjusted gross margin was 34%. The margin for the MCM business was influenced by sales volume, and product mix.
For the full year of 2024 were forecasting total segment adjusted gross margin of 40% to 45% an increase over the 2023 levels, primarily reflecting the full year impact of our profitability improvement efforts.
Finally, we're forecasting Q1 revenue in a range of $200 million to $250 million.
That's all for the financial update I will now turn the call back over to Joe for some final thoughts.
Thank you rich before we go to questions lets take a quick look at slide number 20, I just wanted to reinforce the human impact of our products on public health threats across the world as I stated at the top of the call every six minutes in this country, we lose a life to opioid overdose. So in the past half hour approximately five.
Richard S. Lindahl: Cost Absorption and Inventory Write-Off, and the services segment had revenue of $79 million and segment adjusted gross margin of negative $103 million, influenced by sales volume and costs in the first half of 2023 prior to our restructuring efforts announced on August 8. I'll now turn to slide 18 and touch on Select Balance Sheet and Cash Flow Highlights. We ended 2023 with $112 million in cash and $192 million of total liquidity, including availability under our revolving credit facility. The increase in cash and liquidity versus the prior quarter was due to sales timing and collection of accounts receivable. Operating cash flow for the full year was negative, but in the second half of 2023, it was positive $92 million.
<unk> for taken let me take it one step further and 124 hour period.
We lose approximately 240 individuals it's like losing.
Losing a seven 737 airplanes every day and think about that for just a second.
We are working hard to change this statistic I cannot stress enough that the work we do in support of our mission to protect and enhance slides and ultimately help save lives is what inspires US fall. Thank you again for joining US. This afternoon as you can see the emergent team has made notable progress this year and we look forward to building on this momentum as we.
Executing on our transformation and the important catalysts underway I believe we have an incredible opportunity to play a key role in public health I am excited to work with our team to meet with key stakeholders across the organization and accelerate emergence returned to growth and now we are well positioned for success driven by our focus on protecting communities in addressing the evolving landscape the glue.
Richard S. Lindahl: Capital expenditures were $52 million in 2023. And as of December 31st, our net deposition was $757 million. Turning to 2024 guidance, please see slide 19. As announced in our press release this evening, we are providing guidance for full year 2024 as follows. Total revenues of $900 million to $1.1 billion and commercial product sales of $460 to $500 million, as we expect continued strong demand for Narcan in the U.S. public interest channel in Canada, combined with further growth with OTC Narcan in the retail chain. We're forecasting NCM product sales of $340 to $490 million.
<unk> health challenges I'll look forward to speaking with all of you in the coming months to provide additional detail on perspectives and our near term priorities and goals operator, let's now turn it over to you and open up the floor for Q&A.
Certainly ladies and gentlemen, if you have any questions at this time. Please press star one on your telephone.
That has been answered and you'd like to remove yourself from the queue simply press Star. One again, our first question comes from the line of Jessica Fey from <unk>.
J P. Morgan your question please.
Hey, there good evening, thanks for taking my questions three from me.
First what are the product or asset sales you're considering.
Second if I look at the 2024 commercial products guidance.
Can you just talk about what assumptions underpinning that guidance and just wanted to confirm is that for 2024 is only.
Richard S. Lindahl: As we've previously noted, now that Siphendis is fully licensed, the primary procurement will transition from BARDA to the Strategic National Stockpile. We recognize that the U.S. government is balancing multiple threat preparedness needs with the level of funding provided by Congress, and that this VAC could impact the magnitude and timing of, in particular, anthrax procurements in the near term, even as this potential threat remains a top strategic priority. As a result, we've provided a wide range of potential outcomes for the MCM segment. We continue to engage with our U.S. government stakeholders to improve the procurement visibility that is needed to support this critical capability for the benefit of all United States consumers. As a final note on the MCM products, we continue to see stable, consistent sales to the U.S. government under the long-term contracts we have in place for our plasma and chemical decontamination products, VIGIB, FAT, and RSDL. We're forecasting services segment revenue of $70 to $80 million, reflecting our commitment to serving our existing customers.
<unk> can now and how to think about the OTC contribution versus.
Public interest in Canada.
And then lastly in the MCM guidance.
Can you talk about what that includes as it relates to the size and timing.
<unk> 2000 option as well as Tim Baxter, and maybe a little bit about how to think about the split of revenues between anthrax and smallpox within that guidance. Thank you.
Okay, you had quite a bit there Jessica we're going to try to take them one at a time here and I'll start with the first one on asset sales I think that's probably what's important to say that what I was saying a rich was saying is that we take the need to reduce debt very serious and we are looking at all the opportunities to reduce the debt in our company.
One of the ways that we're looking at is obviously, improving our overall operating performance that goes without saying.
When we're thinking about is what are some of the working capital improvements we can make it also.
One moment, while we resume.
Okay.
Okay.
Okay.
Yes.
One moment, ladies and.
Meanwhile, we resume.
Okay.
Okay.
Okay.
Okay.
Okay.
One moment.
Richard S. Lindahl: Shifting to profitability metrics, we're forecasting adjusted EBITDA of $50 to $100 million, reflecting the impact of our 2023 cost reduction action. Our Capacity Utilization Profile and the Range of Revenue Expectations across our segments. For the full year of 2024, we're forecasting total segment adjusted gross margin of 40 to 45 percent, an increase over the 2023 level, primarily reflecting the full year impact of our profitability improvement effort.
Okay.
[music] okay.
Okay.
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Richard S. Lindahl: Finally, we're forecasting Q1 revenue in a range of $200 to $250 million. That's all for the financial update. I'll now turn the call back over to Joe for some final thoughts. Thank you, Rich.
Okay.
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Joe Papa: Before I go to questions, let's take a quick look at slide number 20. I just want to reinforce the human impact of our products on public health threats across the world. As I stated at the beginning of the call, every six minutes in this country, we lose a life to opioid overdose. So in the past half hour, approximately five lives have been taken. Let me take it one step further. In one 24 hour period, we lose approximately 240 individuals. It's like losing a 737 airplane every day.
Yeah.
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Joe Papa: Think about that for just a second. We are working hard to change that statistic. I cannot stress enough that the work we do in support of our mission to protect and enhance lives and, ultimately, help save lives is what inspires us all. Thank you again for joining us this afternoon. As you can see, the Emergent team has made notable progress this year, and I look forward to building on this momentum as we execute on our transformation and the important catalysts underway. I believe we have an incredible opportunity to play a key role in public health. I'm excited to work with our team, meet with key stakeholders across the organization, and accelerate Emergent's return to growth. I know we are well-positioned for success driven by our focus on protecting communities and addressing the evolving landscape of global health challenges.
Yes.
Okay.
[music] okay.
Okay.
[music].
Joe Papa: I look forward to speaking with all of you in the coming months to provide additional detail on the perspectives and our near-term priorities and goals. Operator, let's now turn it over to you and open up the floor for Q&A. Certainly. Ladies and gentlemen, if you have any questions at this time, please press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again.
Bill.
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Operator: Our first question comes from the line of Jessica Fay from JPMorgan. Your question, please? Hey there, good evening. Thanks for taking my questions. Three from me.
Jessica Fay: What are the product or asset sales you are considering? Second, if I look at the 2024 commercial products guidance. Can you just talk about what assumptions underlie that guidance and just want to confirm if that for 2024 is only NARCAN now and it's how to think about the OTC contribution versus public interest in Canada. And then lastly, in the MCM guidance, can you talk about what that includes as it relates to the size and timing of an ACAM2000 option, as well as Tembexa, and maybe a little bit about how to think Thank you. Okay, you have quite a bit there, Jessica. We're going to try to take them one at a time here. And I'll start with the first one on asset sales.
Okay.
Ladies and gentlemen, please remain on your line your program will resume momentarily. Once again. Please remain on your line your conference call will resume momentarily.
Okay.
[music] okay.
Great.
Okay.
[music].
Joe Papa: I think it's probably most important to say that what I was saying, and Rich was saying, is that we take the need to reduce debt very seriously, and we're looking at all the opportunities to reduce the debt in our company. One of the ways that we're looking at is obviously improving our overall operating performance, that goes without saying. The second one we're thinking about is what are some of the working capital improvements we can make to also. One moment while we resume, www.thevenusproject.com. One moment, ladies and gentlemen, while we resume. One moment.
Yes.
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Operator: Music Ladies and gentlemen, please remain on your line. Your program will resume momentarily. Once again, please remain on your line. Your conference call will resume momentarily. Unknown Attendee, Richard Lindahl, Robert Kramer, Brandon Folkes, Paul Williams, Unknown Attendee, Richard Lindahl, Robert Kramer, Brandon Folkes, Paul Williams, Unknown Attendee, Richard Lindahl, Robert Kramer, Brandon Folkes, Paul Williams, Unknown Attendee, Richard Lindahl, Robert Kramer, Brandon Folkes, Paul Williams, Unknown Attendee, Richard Linda
Okay.
Hi, Joe Bob.
Operator: Jessica, your line is open again. Jessica, this is Joe Papa, the emergency team. Can you hear us? Yes. Do you want me to repeat the question? No. I have the question.
Jessica Your line is open again.
Yes.
Jeff This is Joe pop of the emergent team can you hear us.
Yes.
You want me to repeat the question.
No I have the question and let us start with again, we apologize for not sure what happened with one of the satellite slipped out or something but we're here. We didn't move so we're glad to have kept the finished the question. Okay number. One your question was relative to the question of asset sales and I think what I wanted to say here is number one.
Operator: And let us start. Once again, we apologize for not being sure what happened when one of the satellites went down or something. But we're here; we didn't move.
Joe Papa: So we're glad to have a chance to finish the questions. Okay, number one, your question was related to asset sales. And I think what I wanted to say here is, first of all, that you heard from Richie and myself that we take the reduction in debt very seriously. And we're looking at a number of things to reduce our overall debt structure.
One that you heard from rich and myself that we take the reduction in debt very serious and we are looking at a number of things to reduce our overall debt structure. Obviously the first step is in the operating performance of our business and we're working on that and which took some of those steps already in 2023 and will look to take more than 24 second part of what we're doing is looking.
Joe Papa: Obviously, the first step is in the operating performance of our business, and we're working on that. And Richard took some of those steps already in 2023.
Joe Papa: And we'll look to take more in 24. The second part of what we're doing is looking at working capital management. If we reduce working capital, free up some cash, pay down some debt, that's another important thing we're going to do. And then to your point, the question of looking at product and or asset sales is something that we are evaluating. I hope you understand that I can't go into the specifics of what assets or what products at this time. But we want to just say that we're looking at those to round out the total program we have for debt reduction because we're looking at a very serious initiative for us overall in looking at debt. That's what I wanted to say in the first part of your question. I think the second part was on the commercial and NARCAN. Yeah.
Networking capital management, we've reduced working capital free up some cash pay down some debt. That's the another important thing we're going to do that to your point a question of looking at product and our asset sales is something that we are evaluating I hope you respect I can't go into the specifics of what assets are what product at this time, but we wanted to just say that things.
We're looking at those to round out the total program, we have for debt reduction because we're looking at as a very serious initiative for us So overall net debt.
So that's what I want to say the first part of your question I think the second part was on the commercial area.
Joe Papa: So just to clarify that the commercial guidance only includes NARCAN for 2024. I think that was the first part of your question. And for the second part, I'll ask Paul to elaborate on that. Yeah, so I think first off, I think it's really important to understand that the OTC designation really, for us, expands access across all channels and how can we make Narcan more available in as many access points as possible, I think, particular to the public interest segment. I think we see very strong continued federal and state funding and support of those channels.
Yes, so just to clarify that the commercial guidance only includes Narcan for 2024, I think that was the first part of your question and for the second part I'll ask Paul to elaborate on the assumptions yes.
Yes, So I think first off I think it's really important to understand that the OTC designation really for us expand access across all channels and how can we make narcan more available in as many access points as possible I think particular to the public interest segment I think we see very strong continued federal and state funding in.
Support of those channels.
Paul Williams: On the retail side, I think we have a strong level of retail stock, both in-store and online, and we've started to see consistent demand out of that channel. At the same time, this year, we're going to be expanding further into business-to-business categories, particularly as it relates to industry, tourism, services, entertainment, and construction. That is, I think, also getting a full year's worth of OTC retail sales, too, versus last year.
On the retail side.
I think we can see we are.
We have a strong level of retail stocking both in store and online and we start to see consistent demand out of that channel at the same time. This year, we're going to be expanding further into business into business business to business categories, particularly as it relates to industry tourism services Entertainment and construction.
That is I think also getting a full year's worth of easy retail to diversify here. Thanks, Paul and then the third part of your question was first of all.
Paul Williams: Thanks, Paul. And then the third part of your question was, first of all, you know, how are we thinking about ACAM and Tembexa procurement this year? As far as ACAM is concerned, we are expecting additional procurement this year; we would expect that it would be sometime in the middle part of the year, which is consistent generally with prior practices. And at this point, our expectation is that it's going to be relatively consistent with the level that we saw in 2023 for ACAM.
Hi.
How are we thinking about a cam and <unk> procurement in the year.
As far as <unk> is concerned we are expecting additional procurement. This year, we would expect that it would be sometime in the middle part of the year, which is consistent generally with prior practices.
And at this point, our expectation is that's going to be relatively consistent with the level that we saw in 2023 for head count for.
Richard S. Lindahl: For Tembexa, at this point, we're not anticipating additional procurement of Tembexa this year; that has been deferred into a future period, and we'll certainly keep you posted as that goes on. As far as the Anthrax and Smallpox split, again, as I mentioned earlier, we provided a fairly wide range, really primarily driven by a wide range of expectations around Anthrax, as we look to clarify and get better visibility into what the procurement profile will look like this year for Anthrax. And I've spoken about the Smallpox piece already, so hopefully that addresses your question. I've heard that before.
For Tim Baxter at this.
We're not anticipating additional procurement of <unk>. This year that has been deferred into future period, and we'll certainly keep you.
Posted as that goes on.
As far as the anthrax and smallpox split Tom again, as I mentioned earlier, we provided a fairly wide range really primarily driven by a wide range of expectations around anthrax as we look to clarify and get better visibility into what the procurement profile will look like this year for anthrax.
And I've spoken to that smallpox piece already so hopefully that addresses your question is yes.
Richard S. Lindahl: Let's take our next question, please. Certainly. One moment for our next question. And our next question comes from the line of Frank DeLorenzo from Singular Research. Your question, please. Good afternoon. Thanks for taking my call. I have a couple questions.
Operator, let's take our next question. Please certainly one moment for our next question.
And our next question.
Comes from the line of Frank Dilorenzo.
So from singular research your question please.
Good afternoon, and thanks for taking my call.
I have a couple of questions. The first related to the MCM business and the second related to Narcan. So I'll just start with.
Frank DeLorenzo: The first related to the MCM business and the second related to Narcan. So I'll just start with MCM following along the lines of ACAM2000, assuming there is a positive FDA response to that SBLA toward the end of the year, say the third quarter. How would that additional indication impact the overall sales potential for that product going forward, say in 2025 and beyond? And then, separately from that, could you talk about your next potential submission to the FDA regarding the MCM space? Thanks. Richard, do you want to take this?
MCM.
Following along the lines of.
A cam 2000, assuming there is a positive.
FDA response to that SBA L. A.
Toward the end of the year say third.
Third quarter, how would that additional indication.
Indication impacting overall sales potential for.
That product going forward say in 2025 and beyond and then separate from that could you talk about your next potential.
Submission to the FDA regarding the MCM space.
Yes.
Rich you want to take that sure so.
Richard S. Lindahl: Sure. As you referenced, and as we talked about on the call, we do have the SBLA in front of the FDA to expand the ACAM indication to cover the mPox virus. But at this point, given certainly the timing of that in the year, we are not anticipating any material contribution from mPox in 2024.
You referenced that as we've talked about on the call. We do have the escalade S. BLA in front of the FDA for to expand the <unk>.
Cam indication that cover the pox virus.
At this point given certainly the timing of that and then in the year. We are not anticipating any material contribution from driven by <unk> in 2024. It does provide some incremental upside for the product as we move forward in 'twenty five and beyond.
Richard S. Lindahl: It does provide some incremental upside for the product as we move forward in 2025 and beyond. And so, you know, we'll certainly provide further updates as we go. As far as any other BLAs at this point, there's nothing in the queue immediately, but we certainly continue to work on and investigate other possibilities as we continue to develop different ideas and products. Okay, thanks. Regarding NARCAN, can you give us a little more granularity on the public interest space and getting NARCAN into the first aid kit segment, if you will? I know first aid kits are a big, big deal in a lot of different areas, whether it's schools or industry.
So we will certainly provide further update as we provide.
As far as any other BLA is at this point.
Theres nothing in the queue immediately, but we're certainly continuing to work on and investigate other possibilities.
As we continue to develop our different ideas and products.
Okay. Thanks regarding Narcan can you give us a little more granularity on the public interest space.
And.
Getting narcan into this first aid kit segment. If you will first aid kits are a big big deal and a lot of different areas whether it's.
Schools are industry.
Paul Williams: Has there been any movement there? And separate from that, can you talk about a longer-term XUS strategy for NARCAN? Thank you. Yeah, sure. Thanks for the question. On the first point, the public interest channel in particular, I think we continue to see really strong demand. Obviously, the public interest channel's goal is to get NARCAN into the most vulnerable populations that are suffering from the opioid crisis in as many forms as possible, and we work with those organizations at the local level to enable NARCAN to be in, whether that's in vending machines or other forms that best meet their needs in terms of what they're doing.
Any movement there.
Separate from that could you talk about a longer term and ex U S strategy for Narcan. Thank you.
But I think that yes sure. Thanks for the question.
I think the first point.
The public interest.
<unk> in particular, I think we can see continue to see really strong demand obviously the public interest channel is.
Really their goal is to get narcan into that into the most vulnerable populations that are suffering from the opioid crisis. It has many forms as possible and we work with those organizations at the local level.
Do you have enabled our tam to be and whether that's in vending machines or other put ups.
Meet their needs in terms of what they're doing.
Paul Williams: To my point I mentioned earlier, relative to us moving into, as part of our retail expansion, moving into broader business-to-business targets, getting into first aid kits in the workplace, in restaurants, and other particular areas like that, that is a priority for us this year as we expand in the retail sector. Hi, this is Joe Bob. I had a chance to meet with Paul's team last week, and I can tell you they've got some very exciting plans. And they've looked at a lot of different line extension opportunities, other things that will just continue to expand our presence and, most importantly, just to make sure we have more access available to try to curtail some of these unfortunate opioid overdoses that have occurred.
To my point, I mentioned earlier relative to us moving into that as part of our retail expansion moving into a broader business the business targets getting into first aid kits in the workplace and restaurants and other particular areas like that that is a priority for us this year as we expand in the retail segment.
Hi, This is Joe Bob I had a chance to meet with the team last week.
They've got some very exciting plans and they've looked at a lot of different mine expansion opportunities. Other things that will just continue to expand our presence and most importantly, just to make sure. Our access we have more access available to try to curtail some of these unfortunate opiate overdose if that occurred.
Paul Williams: They've got some exciting plans here to look at new line extensions and opportunities. Your question on the Ex-U.S., similar to what we do in the medical countermeasure space, we work with stakeholders outside the U.S. and multiple other countries, departments of health, ministries of defense, to best understand what their needs are in terms of how they're dealing with the opioid crisis, and we'll work with them to support their needs internationally in terms of whatever direction that goes.
But they've got some plans.
They look at new line extension opportunities kits et cetera.
And to your question on ex U S. Similar to what we do with the medical countermeasure space, we work with our stakeholders.
Outside the U S and in multiple other countries departments of health Ministry.
A ministry of defense.
To understand what their needs are from a from in terms of how they're dealing with the opioid crisis and we'll work with them to support their needs internationally in terms of whatever direction that goes.
Joe Papa: Okay, thank you. Operator, next question. Thank you. Once again, if you have a question at this time, please press star one one, and then this does conclude the question and answer session. I'd like to hand the program back to Joe for any further remarks.
Okay. Thank you.
Operator next question.
Once again, if you have a question at this time, please press star one one.
Okay.
And.
This does conclude the question and answer session I would like to hand, the program back to Joe for any further remarks.
Joe Papa: Well, thank you, everyone, for joining us this afternoon. It's a pleasure to have a chance to share with you some of the excitement we see at Emergent and some of the steps that we're taking today to make sure that we have a bright future for tomorrow. We look forward to meeting with all of you and talking to you in the future as we have a chance to go out and talk about the excitement that we see and opportunities that we're addressing, and importantly, some of the challenges we're addressing up front and taking on head-on. So thank you, everyone, for joining us today. Have a great day, everyone, http://TheBusinessProfessor.com. Thank you all. And 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's website. Thank you again. We look forward to speaking with you all in the future. Goodbye. Alibaba.com
Well. Thank you everyone for joining us this afternoon with pleasure to have the chance to share with you some of the excitement we see an emergent and some of the things that step that we're taking today to make sure that we have a bright future for tomorrow, and we look forward to meeting with all of you and talking to you in the future as we have a chance to go out and talk about the excitement that we see opportunities there.
We are addressing and importantly, some of the challenges we're addressing upfront.
So thank you everyone for joining us today have a great day everyone.
Thank you all and 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 todays call will be available later today and accessible through the investors landing page.
On the company's website. Thank you again, we look forward to speaking with you all in the future Goodbye.
Okay.
Okay.
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