Emergent BioSolutions Inc.

Good day, and thank you for standing by. Welcome to the Q3 2025 Emerging BioSolutions, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automating message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand your conference over to your first speaker today, Frank Vargo, Vice President and Treasurer. Please go ahead.

Good afternoon, everyone. Thanks for joining today as Emergent discusses their operational and financial results for the third quarter of 2025. As is customary, today's call is open to all participants. The call is being recorded and is copyrighted by Emergent BioSolutions. In addition to today's press release, there are a series of slides accompanying this webcast available to all webcast participants. Turning to slide two. During today's call, Mergent may make projections and other forward-looking statements related to their business, future events, 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 the day of this conference call and, except as required by law, Mergent does not undertake to update any forward-looking statements to reflect new information, events, or circumstances. Investors should consider this cautionary statement as well as the risk factors identified in emergency periodic reports filed with the SEC when evaluating their forward-looking statements. During today's call, emergency may also discuss certain non-GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding emergency operating performance. Please refer to the tables found in today's press release. Turning to slide three, the agenda for today's call will include Joe Papa, President and Chief Executive Officer who will provide an update on the company's transformation plan and highlight key results, and Rich Lindahl, EVP and Chief Financial Officer, who will provide details on the third quarter and year-to-date 2025 financial results, as well as provide an update on full-year 2025 guidance. Joe Papa will conclude by discussing the company's business performance and key catalysts for growth, followed by Q&A. Finally, for the benefit of those who may be listening to a replay of this webcast, this call was held and recorded on October 29, 2025. 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 Joe Papa. Joe? Thank you, Frank, and hello, everyone. Welcome to Emergent's third quarter 2025 earnings call. This is Joe Papa, CEO of Emergent, and I'm joined today by Rich Lindahl, our Chief Financial Officer. I will start by providing third quarter highlights, and then Rich will review the third quarter financials. I'll return to review key business catalysts to drive growth. We'll close with a Q&A session. Turning to slide number five, the Emergence team's aspiration is to be the leader in solving public health crisis around the world. As part of our mission to protect and save lives, we develop and deliver highly complex products that address some of the world's most pressing threats. Based on the efforts of our team, We had another great quarter, and we're on track to exceed our initial 2025 revenue and adjusted EBITDA guidance. Year-to-date, we have secured 11 contract modifications and product orders for our biodefense business, while maintaining our market leadership position in the NASEL and LX7 category. We have a durable biodefense business model, has a North America-based supply chain for our product and manufacturing in the U.S., and the USMCA compliant facility. Finally, we believe our differentiated capabilities in plasma and hard to manufacture products position us to be a strategic long-term partner for our customers. Turning to slide six, Emergent was founded 25 years ago, and our business is unlike traditional pharmaceutical companies. In fact, we have the most diversified biodefense and Naloxone product portfolio. It's focused on addressing the global health, public health threats of smallpox, anthrax, mpox, Ebola, botulism, and even opioid overdose emergency situations. Just yesterday, we released a new survey finding that reinforced bioterrorism remains a significant concern to inform public policy leaders. Turning to slide eight, we are making great progress with our multiyear transformation. During 2025, we continue to make strategic investments for the long-term growth while creating significant value for our stakeholders. We are achieving operating margin improvements and validating best options to advance top-line growth while maintaining our attractive cost structure. On slide nine, we provide a more detailed look at the third quarter included, exceeding our internal guidance on both the top and bottom line. Third quarter revenues of $231 million We're $21 million above the high end for our Q3 guidance range of $18210 million. Our profitability continues to improve. And year to date, we have already achieved the high end of our full year adjusted EBITDA guidance range for the $194 million generated as of the third quarter. Both the revenue and profitability of the business exceeded our internal management expectations and the analysts' consensus. Based on the year-to-date performance, we are increasing our adjusted EBITDA balance range $195 to $210 million, up from $175 to $200 million. Our liquidity remains very strong. We now have access to $346 million in financial capacity to invest in additional growth and capital deployment. This includes $246 million of balance sheet cash and our undrawn revolvers. We are pleased with a significant collection of cash for accounts receivable, even during the first days in Q4. We are selectively deploying our capital to create stakeholder value. Our net leverage improved to approximately two times net debt to adjusted EBITDA, down from 3.3 times in the third quarter of 2024. In the third quarter of 2025, we also repurchased some emergent bonds. It continues with our share repurchase program, where we have spent $15.8 million over our $50 million 12-month program. We are excited by the progress of the MCM segment, with four new contract modifications added in the third quarter. We also see upside from our international customers, which represent 34% of our MCM sales year-to-date, which is up from the mid- to high-teens in past years. Our leadership in the lesson remains strong, who are committed as ever to combat the opioid overdose epidemic and saving lives. With two months left in the year, we feel very good about our 2025 performance and are actively working to establish additional growth drivers for 2026 and beyond. On slide 10, we summarize the strong performance of our Naloxone business year to date. We remain the leader in the Naloxone category amongst public interest customers, and we are benefiting from a stabilized U.S. pricing market for Nalaxone. Quarter over quarter, Narcan unit volume grew by 13% and revenue grew by 9%. This sequential growth reaffirms that we have moved past the one-time first quarter events. In fact, Narcan demand remains strong. We expect continued growth of the entire market, which may provide a tailwind to our business. Now I'd like to turn the call over to Rich, who will offer the third quarter financials. Thanks, Joe. Good afternoon, everyone. We appreciate you joining the call. We're off to a strong start in the second half of 2025. Our third quarter revenue came in at $231 million, exceeding the upper end of our guidance range by $21 million, driven by sequential growth of Narcan and the addition of four new contract modifications. Through the third quarter, we continue to see year-over-year improvements in both gross margin and adjusted EBITDA margin, highlighting the efficiency of our business that delivered 38% adjusted EBITDA margin this past quarter. To further highlight our strong performance, net income for the third quarter was $51 million. Year-to-date net income was $107 million, and year-to-date earnings per share was $1.89 million. Year-to-date performance has also exceeded our internal expectations. We're raising our total revenue guidance to a range of $775 to $835 million, a $5 million improvement at the midpoint. And we're increasing our adjusted EBITDA guidance to a range of $195 to $210 million, a $15 million increase at the midpoint as compared to our prior forecast. The profitability and cash generation of our company has allowed us to focus on creating opportunities to generate additional shareholder value. In the third quarter, we deployed cash towards both equity and debt repurchases, taking advantage of opportunistic pricing. Even with these actions, our cash position and leverage ratio remained in a strong and stable position. Both of our business segments outperformed in the quarter, and importantly, we saw no disruption from external macro factors that may be pressuring the rest of Biopharma. we continue to play a vital role as a trusted partner to both the U.S. government and our international partners with growing demand for our medical countermeasures as nations prioritize preparedness and response capabilities. Please turn to slide 12 to review our third quarter financials. I'll start by noting that the prior year comparisons fully reflect our restructuring actions from early 2024. Highlights of the quarter include total revenues of $231 million, As a reminder, third quarter of 2024 benefited from a partial quarter of now divested revenues from RSDL and the CAMDI facility. Adjusted EBITDA margin of 38%, an increase of 200 basis points versus the prior year, underscoring our continued strong profitability with our efficient platform. Adjusted gross margin of 61% improved 200 basis points year over year, driven by a more favorable product mix. the expansion of strategic global partnerships, and a leaner cost structure stemming from our divestitures and restructuring initiatives. And finally, operating expenses of $52 million were $38 million lower compared to the prior year. Of note, you can see that our SG&A spend declined roughly 50% from last year. Additional third quarter revenue details can be found in the appendix. Turning to slide 13, I'll walk through our performance for the first nine months of 2025. Total revenues were $594 million, a decline compared to the prior year, reflecting the divestitures, the J&J one-time settlement in 2024, and strategic pricing actions taken on Narcan. Justed EBITDA was $194 million, or 33% of total revenues, an improvement of approximately $32 million and 1,400 basis points year-over-year. This outcome illustrates our strong operating leverage, the impact of our restructuring actions, as well as a favorable product mix in 2025, driven by international MCM sales. Adjusted gross margin of 57% improved 1100 basis points compared to the prior year. This expansion was driven by product mix and continued operational efficiencies stemming from the 2024 initiatives. Operating expenses totaled $176 million, a $133 million reduction from the prior year. Most of this reduction came from a $112 million decline in SG&A, while we preserved critical R&D capabilities to support long-term growth. Moving on to slide 14, for the first nine months of 2025, total revenue was $594 million driven by total product sales of $545 million. As noted, 2024 includes revenue associated with one-time events and divested assets. The table in the upper right corner of slide 14 normalizes 2024 revenue for these items. With that, let's break down performance by key product lines. Meloxone nasal spray revenue totaled $188 million, reflecting improved sequential momentum from the second and third quarters. Anthrax medical countermeasure revenue was $61 million, based on the timing of government procurement orders. Smallpox revenue was $231 million, an increase of $30 million, or 15%, reflecting deliveries under multi-year contracts and increased international orders. Lastly, other revenues were $49 million. As a reminder, last year's revenues included $50 million from the Janssen settlement, as well as the Camden facility revenue prior to its divestiture in August 24. Normalizing for these items, other revenues grew $25 million year over year, due to increased services demand in our Winnipeg facility, along with CNG revenue related to our Devanga development program. Turning to slide 15, I'm pleased to report continued progress in strengthening our financial position. For the third quarter of 25, total liquidity was $346 million, comprised of $246 million of cash and $100 million of undrawn revolver capacity. Liquidity improved $96 million year-over-year. As of September 30, our gross debt was $693 million, down about $7 million versus prior year, driven by our unsecured bond repurchases during the quarter. Total net debt in Q3 2025 was $448 million, a $103 million, or 19% reduction. Our net leverage remained in the two-times-adjusted EBITDA range at the end of the third quarter, as we both increased profitability and reduced gross debt. We also collected significant accounts receivable from late September MCN deliveries in early October, despite the current U.S. government shutdown, further enhancing our operating cash flow. This outcome further reinforces the importance of our business. Please turn to slide 60. Our capital allocation priorities are focused on three key areas, growth, debt repayment, and share repurchases. We're investing in both organic and inorganic opportunities to strengthen our core businesses and drive future revenue expansion. Some important tailwinds include increasing international revenue from our medical countermeasures segment and our stronger balance sheet, which enables business development. We remain very judicious stewards of shareholder capital and continue to evaluate opportunities to advance internal R&D projects. Next, we continue to prioritize debt repayment to strengthen our balance sheet and improve financial flexibility. Beginning in August, we initiated a $30 million bond repurchase program, and during the quarter, retired $6.9 million in principal amount of unsecured bonds for $5.8 million of cash. We are also committed to creating shareholder value through the 12-month, $50 million share repurchase program we announced in March 2025. In the third quarter, we repurchased another 1.1 million shares for $8.9 million, bringing us to $2.3 million repurchase year-to-date for $15.8 million, or an average price of $7 per share. We remain opportunistic with buybacks in future quarters as we evaluate market conditions and other factors. Transitioning to slide 17, we are updating our full year 25 guidance by raising the midpoints of our revenue and profitability metrics. Further details are as follows. Total revenues of $775 to $835 million, an increase of $5 million at the midpoint. Adjusted EBITDA in the range of $195 to $210 million, an improvement of $15 million at the midpoint. We're also raising our adjusted gross margin guidance to a range of 52% to 54%, a 200 basis point improvement over our prior guidance at the midpoint. Based on the strong performance year-to-date across our segments, We're also raising the midpoint of our medical countermeasures product revenue guidance while maintaining our prior guidance range for commercial products. Segment revenue guidance is as follows. MCM product sales are $450 to $475 million. We continue our enduring partnership with the U.S. government, which is further evidenced by the 11 contract modifications we've received year-to-date for our medical countermeasure products. Commercial products, including Klaxata, in the range of $265 to $300 million. Year-to-date, commercial product sales were $188 million, with stable pricing across the U.S. public interest channel. Our performance in 2025 reinforces our market-leading position in the opioid overdose reversal space. In closing, on slide 18, we're continuing the turnaround phase of our multi-year plan with solid performance in the first nine months of 2025. Our 2025 revenue outlook remains focused on our core business across both the medical countermeasures and commercial segments. Of note, international sales now represent 34% of the company's MCM segment, which is up meaningfully from the high teens in prior years. We are closely monitoring this trend and making targeted investments to facilitate this growth. Our partnership with the U.S. government and international customers remains strong, as evidenced by the 11 contract modifications here to date. Our gross margins and profitability have continued to improve throughout the year, and we're generating positive operating cash flow while enhancing our liquidity position. Our leverage ratio is stable at approximately two times the destiny it does. Looking ahead, our plan remains consistent. We're pursuing strategic growth investments while actively seeking opportunities to deliver value to our shareholders. I'll now turn the call back to Joe to discuss our business outlook and catalysts. Joe. Thank you, Rich. Turning to slide 20, let's begin with our Naloxone business. Our entire emergent organization is proud of the tangible impact that Narcan has of saving many lives from opioid overdoses in the United States and Canada. Next month, we will recognize the 10-year anniversary of the U.S. FDA approval of the prescription Narcan nasal spray. We will highlight the tremendous work that is going to expand its access to its over-the-counter availability in 2023. And with ongoing efforts to expand Narcan access, added Foxado into our Narcan direct platform for ease of purchasing, combined with the over $50 billion in opioid litigation settlement dollars, we believe that our portfolio will continue to align the overall Naloxone market growth expectations. Moving to slide number 41, I'd like to review the key results from our recent biodefense survey. There is significant bipartisan support favoring biothreat preparedness. The bottom line is that amongst policy opinion leaders, the perceived risk of bioterror threats is high, and bioterrorism even outpaces concerns about nuclear risk. This is because biological attacks are viewed to be more feasible, more imminent, and those surveyed were concerned about the overall preparedness. This quarter, we secured four new U.S. government contracts worth approximately $155 million combined. We also successfully secured an incremental $29 million in MCM product orders with an international government partner. International sales have been a key growth driver in 2025 and represent 34% of our MCM sales year-to-date, which is meaningfully higher for prior years. On the public health front, the emergency team was in continuous communication with our IBANGA commercial partner, Ridgeback Biotherapeutics. Ridgeback along with other organizations and local health authorities, directly supported efforts during the recent Ebola outbreak in the Democratic Republic of Congo. This outbreak, which is one of several over the last five years, is a stark reminder of the continued frequency and threat for the Ebola virus disease. Global readiness and resilience are key to being prepared for the next potential outbreak. Earlier this year, we announced our continued collaboration with BARDA, to advance EVAGA development towards supply and treatment, ensuring we are prepared against Ebola. On slide 22, we outline our outlook on future growth and cash deployment. Our plan is to invest the cash we are generating from our profitable business segments into two growth tracks. First, exploring government collaborations for new biodefense products. The second is to identify value creating external commercial programs that align strategically for their current business model capabilities. In summary, on slide number 25, we have outperformed our top line in adjusted EBITDA guidance expectations in the third quarter. We are raising our full-year revenue guidance while also raising our adjusted EBITDA guidance to $195 to $210 million. Throughout 2025, our operating margin and cash flow have grown significantly as we execute our multi-year turnaround plan. In conclusion, we have a unique and diversified biodefense portfolio. We are proud leaders addressing the overdose epidemic through our life-saving naloxone products. We will take additional steps to generate value for all our stakeholders, and we will strive to the highest standards of quality, ethics, and compliance for the entire emergent enterprise. So with that, I look forward to taking your questions. Operator, if you'll please open up the line for questions.

Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Jess Fye from JP Morgan. The floor is yours.