Core Insights - Emergent BioSolutions Inc. has secured approximately $27 million in international orders for its medical countermeasures (MCM) portfolio, aimed for delivery in 2025, addressing threats like smallpox and anthrax [1][2] - The company emphasizes its role as a trusted partner in supplying medical countermeasures globally, supporting health preparedness efforts [2] - Emergent is focused on international expansion and strengthening health preparedness as part of its multi-year transformation plan [2][3] Company Overview - Emergent BioSolutions has over 25 years of experience in preparing for public health threats, providing solutions for various health emergencies including smallpox, anthrax, and Ebola [3] - The company aims to protect and save lives by delivering life-saving solutions and enhancing community preparedness against health challenges [3] Market Position - The types and quantities of medical countermeasures maintained in stockpiles depend on population needs, available products, and government resources [2]

Core Insights - Emergent BioSolutions Inc. is enhancing partnerships to improve opioid emergency preparedness as overdose death rates decline for the first time in five years [1] - The company is focusing on expanding access to NARCAN® Nasal Spray and educating the public on responding to opioid overdoses [1][2] Group 1: NARCAN® Nasal Spray Initiatives - NARCAN® Nasal Spray is the first FDA-approved over-the-counter naloxone product for emergency opioid overdose treatment [2][6] - Emergent is collaborating with the NYC Building & Construction Industry Safety Fund to launch the HOPE/LIVES educational program, which trains construction workers on recognizing opioid overdoses and administering NARCAN® [2] - Each construction worker will receive an opioid emergency kit containing two doses of NARCAN® to prepare for emergencies [2] Group 2: Partnerships and Community Support - Emergent is working with Pathway Healthcare to provide NARCAN® Nasal Spray at its Mississippi locations, enhancing safety for patients affected by opioid use disorder [3][4] - Pathway Healthcare emphasizes the importance of making naloxone readily available in clinics to provide immediate support to at-risk individuals [4] - The initiative aims to create a supportive environment for patients and their families, reducing stigma around seeking help [5] Group 3: Industry Impact and Advocacy - The decline in opioid overdose deaths highlights the effectiveness of increased education and access to naloxone [5] - Emergent BioSolutions advocates for a united effort among various stakeholders, including advocacy groups and government officials, to combat opioid overdose deaths [5] - The company aims to ensure that every individual and venue is prepared to respond to opioid emergencies [5]

Core Insights - Emergent BioSolutions Inc. has entered into a strategic financial investment agreement with Rocketvax Ltd to support research and development in biotechnology [1][2] - The partnership will focus on U.S. manufacturing and commercialization of four pipeline candidates targeting infectious diseases, cancer, and autoimmune disorders [2] - Rocketvax's leading candidate is a live-attenuated nasal spray SARS-CoV-2 vaccine, showing superior efficacy compared to mRNA vaccines in animal studies [3] Company Overview - Emergent BioSolutions is a public health company dedicated to delivering protective and life-saving solutions for various health threats, including smallpox and Ebola [5] - Rocketvax Ltd specializes in next-generation vaccines using proprietary molecular biology technologies, aiming to enhance vaccine stability and distribution [6] Strategic Goals - The collaboration aims to accelerate the development of innovative products addressing significant public health challenges, aligning with Emergent's multi-year transformation plan [4] - The partnership is expected to revolutionize disease prevention and immunotherapy, providing life-saving solutions globally [4]

GAITHERSBURG, Md., March 10, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has entered into an agreement to sell its Baltimore-Bayview drug substance manufacturing facility to Syngene International, a leading global contract research, development, and manufacturing organization, for a total value of $36.5 million. The Bayview site includes manufacturing, laboratory, warehousing and office space, and is fitted with multiple monoclonal antibody (mAbs) manufacturing lin ...

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were $195 million, a decrease compared to the previous year due to lower NARCAN sales and Amtrac sales timing, partially offset by an adjusted EBITDA of $21 million, which is an increase of $18 million year-over-year [27] - Full-year 2024 total revenues were approximately $1.04 billion, roughly flat compared to the prior year, with total adjusted EBITDA of $183 million, a significant improvement from a negative $22 million in 2023 [29] - Operating expenses for the full year were $379 million, down $101 million or 21% year-over-year, reflecting cost actions taken in the second half of 2024 [30] Business Line Data and Key Metrics Changes - Total product sales for 2024 were $909 million, a slight decline from the previous year, with increased smallpox revenue offset by lower NARCAN sales [30] - NARCAN maintained a competitive price and market-leading distribution capabilities, with full-year volume consistent with 2023 levels, although prices were lower compared to 2023 [31] Market Data and Key Metrics Changes - The company distributed 11 million two-dose cartons (22 million doses) of NARCAN across the US and Canada, maintaining a market leadership position in the growing naloxone nasal spray market [18] - The naloxone market is expected to grow by mid to high single-digit rates, with NARCAN holding approximately 75% market share [50] Company Strategy and Development Direction - The company is executing a multi-year transformational plan aimed at stabilizing and ultimately transforming the business to generate long-term profitable growth [14] - Key goals for 2025 include strong profit follow-through from 2024, rebuilding the product pipeline, optimizing manufacturing operations, and strategic capital deployment for growth opportunities [20] Management's Comments on Operating Environment and Future Outlook - Management expressed a conservative approach to 2025 guidance due to potential shifts in government administration and timing uncertainties [22] - Despite a conservative outlook, management anticipates a strong first quarter of 2025, supported by the momentum from 2024 [40] Other Important Information - The company secured $550 million in MCM contract awards in 2024 and resolved legacy legal and quality issues, improving quality and compliance systems [19] - The company has a total liquidity of $200 million at the end of 2024, with net debt reduced to $601 million, a 21% decrease since the beginning of 2024 [36] Q&A Session Summary Question: Can you provide specifics on NARCAN guidance regarding volume and price? - Management noted that pricing stabilized in the second half of 2024, but a follow-through impact from previous price reductions is expected to affect full-year results [67][69] Question: How do you see adjusted EBITDA evolving in 2026 and beyond? - Management indicated that growth opportunities exist through diversification of the product portfolio and additional business development efforts [72][76] Question: What is the outlook for Kloxado in the market? - Management plans to leverage existing distribution capabilities to facilitate Kloxado's market entry and expects it to complement NARCAN in addressing fentanyl overdoses [84][86] Question: Is Kloxado already available within the NARCAN direct system? - Management confirmed that logistics are being worked out and expects Kloxado to be available within 30 to 60 days [93] Question: What are the expectations for near-term contract adjustments for BioDefense products? - Management anticipates continued execution of contracts and procurement orders from the US government, similar to the patterns seen in 2024 [99]

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were $195 million, a decrease compared to the prior year due to lower NARCAN sales and Amtrac sales timing, partially offset by adjusted EBITDA of $21 million, an increase of $18 million year-over-year [27] - Full-year 2024 total revenues were approximately $1.04 billion, roughly flat compared to the prior year, with total adjusted EBITDA of $183 million, a positive swing of $205 million from a negative $22 million in 2023 [29] - Total adjusted gross margin for 2024 was $457 million, an annual improvement of $121 million or 1200 basis points as a percentage of revenue [29] Business Line Data and Key Metrics Changes - Total product sales for 2024 were $909 million, a slight decline from the prior year, with increased smallpox revenue offset by lower NARCAN sales [30] - NARCAN maintained a competitive price and market-leading distribution capabilities, with full-year volume consistent with 2023 levels [31] - The company achieved $130 million in reduced operating expenditures while meeting core product commitments [17] Market Data and Key Metrics Changes - Emergent BioSolutions distributed 11 million two-dose cartons (22 million doses) of NARCAN across the US and Canada in 2024, maintaining a leading market share in the growing naloxone nasal spray market [18] - The company secured $550 million in medical countermeasure (MCM) contract awards in 2024, supporting public health preparedness [19] Company Strategy and Development Direction - The company is executing a multi-year transformational plan aimed at stabilizing and ultimately transforming the business to generate long-term profitable growth [14] - Key goals for 2025 include strong profit follow-through from 2024, rebuilding the product pipeline, optimizing manufacturing operations, and strategic capital deployment for growth opportunities [20] - The company is focused on addressing public health threats and expanding access to NARCAN, with plans to leverage its distribution capabilities for Kloxado nasal spray [53][84] Management's Comments on Operating Environment and Future Outlook - Management expressed a conservative approach to 2025 guidance due to potential shifts in government administration and timing uncertainties [22] - Despite a conservative outlook, management anticipates a strong first quarter of 2025, supported by the momentum from 2024 [100] - The company is optimistic about the potential for growth in its MCM products and the ongoing support for biodefense initiatives [55] Other Important Information - The company completed $117 million in asset sales and received a $50 million payment from Janssen Pharmaceuticals as part of a settlement agreement [33] - Total liquidity at the end of 2024 was $200 million, with net debt reduced by $156 million or 21% since the beginning of 2024 [36] Q&A Session Summary Question: Can you provide specifics on NARCAN guidance regarding volume and price? - Management noted that pricing stabilized in the second half of 2024, but a follow-through impact from prior reductions is expected to affect full-year results [67][68] Question: How do you see adjusted EBITDA evolving in 2026 and beyond? - Management indicated that diversification of the business and additional organic opportunities will contribute to growth in adjusted EBITDA, but specifics for 2026 were not provided [72][76] Question: What is the outlook for Kloxado's market positioning? - Management plans to leverage existing distribution capabilities to facilitate access to Kloxado, particularly in response to increasing fentanyl overdoses [84][86] Question: Is Kloxado already available within the NARCAN direct system? - Management confirmed that logistics are being worked through, with expectations for Kloxado to be available in the next 30 to 60 days [93][94] Question: What are the expectations for near-term contract adjustments for BioDefense products? - Management expects the US government to continue executing contracts and issuing procurement orders throughout 2025, following the pattern established in 2024 [99]

Q4 2024 & Full Year Financial Results March 3, 2025 1 Safe Harbor Statement/Trademarks This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the future performance of the Company or any of our businesses, our business strategy, future operations, future financial position, future revenues and earnings, our ability to achieve the objectives of ou ...

Company Performance - Emergent Biosolutions reported quarterly earnings of $0.05 per share, surpassing the Zacks Consensus Estimate of a loss of $0.35 per share, and showing improvement from a loss of $0.77 per share a year ago, resulting in an earnings surprise of 114.29% [1] - The company posted revenues of $194.7 million for the quarter ended December 2024, which missed the Zacks Consensus Estimate by 22.93% and decreased from year-ago revenues of $276.6 million [2] - Over the last four quarters, Emergent Biosolutions has exceeded consensus EPS estimates two times and topped consensus revenue estimates only once [2] Stock Performance - Emergent Biosolutions shares have declined approximately 21.8% since the beginning of the year, contrasting with the S&P 500's gain of 1.2% [3] - The current Zacks Rank for Emergent Biosolutions is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is $1.14 on revenues of $320.46 million, while the estimate for the current fiscal year is $2.07 on revenues of $1.13 billion [7] - The outlook for the Medical - Biomedical and Genetics industry, where Emergent Biosolutions operates, is currently in the top 28% of over 250 Zacks industries, suggesting a favorable environment for stock performance [8]

Product Portfolio and Revenue - As of December 31, 2024, the company has a product portfolio of 10 actively developed and marketed products, generating substantial revenue[18]. - The company received approximately $223 million in new U.S. Government orders for products including ACAM2000, VIGIV CNJ-016, and BAT during fiscal year 2024[31]. - The company has a contract valued at up to approximately $2.0 billion over 10 years for the continued supply of ACAM2000 vaccine, with a base period valued at approximately $170 million[34]. - The company’s services segment includes drug substance manufacturing and development services, supporting both internal products and third-party projects[26]. - The company’s product portfolio includes ACAM2000 and BioThrax, which are the only FDA-approved anthrax vaccines procured by the U.S. government[55]. Organizational Restructuring and Workforce - The company initiated multiple organizational restructuring plans in 2023 and 2024, resulting in a workforce reduction of approximately 370 employees and the closure of several facilities[27]. - As of December 31, 2024, the company had approximately 900 employees globally, a decline of about 700 employees during 2024 due to organizational restructurings and facility sales[117]. - The company initiated multiple organizational restructuring plans in 2024, resulting in a workforce reduction of approximately 300 employees and the closure of several facilities[127]. Financial Position and Contracts - The company refinanced its credit facility on August 30, 2024, securing a term loan of $250 million to strengthen its financial position[29]. - The company entered into a Revolving Credit Agreement on September 30, 2024, providing for asset-based revolving loans of up to $100 million[30]. - The Company sold an underutilized warehouse for approximately $7.0 million and received $50.0 million from a settlement agreement with Janssen Pharmaceuticals, leading to a debt reduction of approximately $200 million and annualized savings of about $130 million[29]. - The Company entered into a Term Loan Agreement for $250.0 million, drawn in full, to refinance its credit facility and repay outstanding amounts under the previous credit agreement[29]. - A new credit agreement for asset-based revolving loans was established, providing commitments of up to $100.0 million, with a maximum amount of $125.0 million[30]. Regulatory Approvals and Compliance - ACAM2000 vaccine received a Notice of Compliance from Health Canada on December 5, 2023, for active immunization against smallpox for high-risk individuals[34]. - The FDA acknowledged the shelf-life extension of NARCAN Nasal Spray from 36 months to 48 months based on four-year stability data[37]. - The FDA may impose conditions upon approval, which could negatively impact the commercial success of a product[78]. - The FDA requires that drugs be manufactured in FDA-registered facilities and in accordance with Current Good Manufacturing Practices (CGMPs)[99]. - The FDA's regulations limit the scope of orphan drug exclusivity to a product's approved uses or indications[89]. Product Development and Clinical Trials - The company conducts pre-clinical safety and efficacy testing on product candidates before initiating clinical trials[69]. - The EBS-LASV vaccine candidate completed Phase 1 clinical trials but did not meet the specified immunogenicity endpoint and will not progress to Phase 2[40]. - Clinical trials are conducted in three phases, with Phase 3 trials assessing clinical efficacy and safety in a larger population[76]. - The FDA's "Animal Rule" allows for product approval based on animal study data when human trials are unethical or unfeasible[70]. - The company has four development and manufacturing sites in the U.S. and Canada to support internal manufacturing and external services[47]. Market Competition and Challenges - NARCAN Nasal Spray faces increasing competition from generic versions launched by Teva and Padagis, as well as new branded products like OPVEE and Rezenopy[56]. - ACAM2000 vaccine remains the primary smallpox vaccine stockpiled by the US government, facing competition from JYNNEOS and KM Biologics LC16m8 vaccines[55]. - CYFENDUS and BioThrax are the only anthrax vaccines procured by the US government, with potential future competition from candidates developed by GC Pharma and Blue Willow Biologics[55]. - TEMBEXA, the first oral antiviral approved for smallpox, competes with TPOXX, which is also approved for multiple indications including mpox and cowpox[59]. Strategic Focus and Future Plans - The company plans to focus on international expansion and growth of existing segments to maintain revenue diversification in 2025[32]. - The company aims to stabilize and transform its operations while maintaining a commitment to public health through lifesaving products[28]. - For 2025, the Company aims to focus on turnaround strategies, emphasizing patient safety, revenue diversification, and international expansion[32]. - The company plans to leverage bipartisan support to drive business growth and seek new opportunities aligned with internal capabilities[32]. Intellectual Property and Compliance - The company actively seeks to protect its intellectual property through patents, trademarks, and trade secrets, while respecting the rights of others[60]. - The company is subject to strict regulations as a US government contractor, including potential penalties and compliance audits[62]. - The company maintains a global corporate compliance program to mitigate healthcare fraud and abuse risks[109]. Government Contracts and Funding - The Project BioShield Act provided $5.6 billion over 10 years to develop and stockpile medical countermeasures for public health emergencies[63]. - The Pandemic and All Hazards Preparedness Act established BARDA to support the development and procurement of medical countermeasures, continuing funding through various reauthorizations[64]. - The Public Readiness and Emergency Preparedness Act (PREP Act) provides liability immunity for manufacturers of MCMs, with declarations covering anthrax and botulinum toxin expiring on December 31, 2027, and smallpox and mpox expiring on December 31, 2032[67].

Financial Performance - Q4 2024 total revenues were $194.7 million, a decrease of 30% compared to Q4 2023 revenues of $276.6 million[3]. - Q4 2024 net loss was $31.3 million, a 37% improvement from a net loss of $49.5 million in Q4 2023[3]. - Adjusted EBITDA for Q4 2024 was $21.0 million, representing a 518% increase from $3.4 million in Q4 2023[3]. - Full year 2024 total revenues were $1.04 billion, slightly down by 1% from $1.05 billion in 2023[4]. - Full year 2024 adjusted EBITDA was $183.1 million, a significant recovery from a loss of $22.3 million in 2023[4]. - Total revenues for the year ended December 31, 2024, were $1,043.6 million, a slight decrease of 0.5% compared to $1,049.3 million in 2023[50]. - Net loss for the year ended December 31, 2024, was $190.6 million, compared to a net loss of $760.5 million in 2023, indicating a significant improvement[52]. - Cash provided by operating activities for the year ended December 31, 2024, was $58.7 million, a recovery from cash used of $206.3 million in 2023[52]. - The company reported a basic loss per common share of $3.60 for the year ended December 31, 2024, compared to $14.85 in 2023, reflecting a reduction in losses[50]. - Adjusted net income for the year ended December 31, 2024, was a loss of $12.1 million, compared to a loss of $319.0 million in 2023[56]. Revenue Sources - Revenues from NARCAN decreased by $45.9 million, or 41%, in Q4 2024 compared to Q4 2023[8]. - Revenues from Smallpox MCM products increased by $65.0 million, or 565%, in Q4 2024 compared to Q4 2023[9]. - MCM Products segment revenue is expected to be between $435 million and $485 million for 2025, down from $509.8 million in 2024[31]. - The revenue from the Settlement Agreement with Janssen contributed $50.0 million to the total segment results for 2024[62]. Cost Management - Total operating expenses for Q4 2024 were $204.2 million, a decrease of 36% from $320.4 million in Q4 2023[13]. - Capital expenditures for Q4 2024 were $1.7 million, down 85% from $11.4 million in Q4 2023[18]. - Operating expenses for the year ended December 31, 2024, totaled $1,152.3 million, down 35% from $1,775.7 million in 2023[50]. - Research and development expenses for the year ended December 31, 2024, were $70.7 million, down from $111.4 million in 2023, indicating a focus on cost management[50]. - The company incurred interest expenses of $71.0 million for the year ended December 31, 2024, compared to $87.9 million in 2023, showing a reduction in financing costs[52]. Gross Margin Analysis - Commercial Products segment gross margin decreased by $29.1 million, or 57%, to $22.4 million for the quarter ended December 31, 2024, with a gross margin percentage of 34%, down from 46% in the prior year[21]. - MCM Products segment gross margin increased by $3.8 million, or 11%, to $37.9 million for the quarter ended December 31, 2024, with a gross margin percentage of 32%, up from 25% in the prior year[22]. - Services segment gross margin improved by $11.7 million, or 69%, to $(5.3) million for the quarter ended December 31, 2024, with a gross margin percentage of (72)%, up from (82)% in the prior year[24]. - For the year ended December 31, 2024, Commercial Products segment gross margin decreased by $73.2 million, or 29%, to $175.2 million, with a gross margin percentage of 44%, down from 50% in the prior year[26]. - MCM Products segment gross margin increased by $148.5 million, or 130%, to $263.1 million for the year ended December 31, 2024, with a gross margin percentage of 52%, up from 26% in the prior year[27]. - Services segment gross margin decreased by $60.1 million, or 54%, to $(171.1) million for the year ended December 31, 2024, with a gross margin percentage of (163)%, down from (141)% in the prior year[29]. - Total segment adjusted gross margin for 2024 was $456.7 million, with an adjusted gross margin percentage of 45%, compared to 33% in 2023[62][64]. Future Projections - The company is guiding for 2025 adjusted EBITDA in the range of $150 million to $200 million[4]. - The company forecasts total revenues for full year 2025 to be between $750 million and $850 million, down from $1,043.6 million in 2024[31]. - The forecast for net income (loss) for 2025 is projected to be between $16 million and $66 million, compared to a loss of $190.6 million in 2024[31]. - The forecasted total segment gross margin for 2025 is estimated to be between $278 million and $351 million, with a gross margin percentage of 38% to 43%[68]. - Adjusted net income for 2025 is forecasted to be between $20 million and $70 million[65]. - Adjusted EBITDA for 2025 is projected to be between $150 million and $200 million[66]. Asset and Liability Management - Total assets decreased from $1,823.2 million in 2023 to $1,389.7 million in 2024, a decline of approximately 23.8%[48]. - Total current liabilities reduced significantly from $651.3 million in 2023 to $162.4 million in 2024, a decrease of about 75.1%[48]. Operational Strategy - The company anticipates future performance improvements based on restructuring initiatives and divestitures, although specific projections were not provided[43]. - The company is focused on maintaining compliance with quality standards in manufacturing operations to secure future government contracts[44]. - The impact of organizational changes announced in 2023 and 2024 is expected to influence operational efficiency and market positioning[45]. - The company is actively pursuing new business acquisitions and collaborations to enhance its product portfolio and market reach[45].