UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33137 EMERGENT BIOSOLUTIONS INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 14-1902018 (State or Other Jurisdiction o ...

EMERGENT BIOSOLUTIONS REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS FINANCIAL HIGHLIGHTS (1) "We delivered a strong quarter with growth across all our key products," said Joe Papa, President and CEO at Emergent. "We also took significant actions to improve our debt position, reduce operating expenses and strengthen our financial flexibility. Emergent's transformation will not happen overnight. The actions we are implementing today, combined with the assets Emergent possesses, will enable us to move faster, r ...

Proactive changes aim to ensure long-term sustainability and growth, optimize operations, streamline processes, and allocate resources more efficientlyReorganization will align with evolving business goals, strategic priorities and new operational planOverall efforts expected to deliver annual cost savings of approximately $80 million  GAITHERSBURG, Md., May 01, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE:EBS) today announced the next phase of its new operational plan that consolidates operations, ...

Nearly 9 in 10 Americans surveyed agree opioid overdoses are a concern for teenagers and college students; parents in the survey want life-saving treatment to be easily accessible in case of an emergency GAITHERSBURG, Md., May 01, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the results of a new national public opinion survey showing that more than 90 percent of Americans surveyed recognize opioid overdoses are a pressing concern for teenagers and college students, and more ...

GAITHERSBURG, Md., April 30, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced that it has entered into a "Consent, Waiver and Seventh Amendment" to its existing credit facility. "In light of this amendment, Emergent now has an extended runway to execute on our go-forward business plan to stabilize our financial position," stated Joe Papa, president and CEO of Emergent. "Our bank group continues to work with our management team in a constructive fashion, evidenced by this positive dev ...

GAITHERSBURG, Md., April 22, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) will host a conference call on Wednesday, May 1, 2024, at 5:00 pm eastern time to discuss the financial results for the first quarter 2024, key business updates, revenue guidance for the second quarter of 2024, and financial outlook for full year 2024. Conference Call InformationParticipants can access the conference call live via webcast. To participate via telephone, please register in advance at this link. Upon re ...

GAITHERSBURG, Md., April 22, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) will host a conference call on Wednesday, May 1, 2024, at 5:00 pm eastern time to discuss the financial results for the first quarter 2024, key business updates, revenue guidance for the second quarter of 2024, and financial outlook for full year 2024. Conference Call InformationParticipants can access the conference call live via webcast. To participate via telephone, please register in advance at this link. Upon r ...

Emergent BioSolutions (EBS) reported an adjusted loss of 77 cents per share in fourth-quarter 2023, wider than the Zacks Consensus Estimate of a loss of 33 cents. In the year-ago quarter, EBS reported adjusted earnings of 11 cents per share.Revenues in the quarter totaled $276.6 million, down 16% from the prior-year period’s level. The reported figure outpaced the Zacks Consensus Estimate of $247.6 million.The company's shares lost almost 16% in after-market trading on Mar 6, likely due to the earnings miss ...

PART I [Business](index=6&type=section&id=Item%201.%20Business) Emergent BioSolutions is a global life sciences company focused on public health threats, operating through Commercial, MCM, and Services segments, executing a strategic plan to strengthen its financial position - The company is a global life sciences company providing solutions for accidental, deliberate, and naturally occurring public health threats (PHTs) across CBRNE, EID, public health crises, and acute care categories[17](index=17&type=chunk)[20](index=20&type=chunk) - In Q4 2023, the company realigned its business into three reportable segments: **Commercial Products**, **MCM Products**, and **Services**[18](index=18&type=chunk)[21](index=21&type=chunk) - In 2023, the company executed significant strategic actions, including divesting its travel health business, implementing over **$160 million** in annualized operating expense savings, and de-emphasizing its CDMO business[24](index=24&type=chunk) - On May 15, 2023, the company completed the sale of its travel health business, including Vivotif® and Vaxchora®, to Bavarian Nordic[19](index=19&type=chunk) [Primary Products and Product Candidates](index=9&type=section&id=Primary%20Products%20and%20Product%20Candidates) The company's portfolio includes government-procured Medical Countermeasures (MCMs), commercial products like NARCAN® Nasal Spray, and a diverse development pipeline Government - MCM Products Portfolio | Product | Indication(s) | | :--- | :--- | | **ACAM2000®** | Active immunization against smallpox disease | | **ANTHRASIL®** | Treatment of inhalational anthrax | | **BAT®** | Treatment of symptomatic botulism | | **BioThrax®** | Pre- and post-exposure prophylaxis for anthrax disease | | **CYFENDUS®** | Post-exposure prophylaxis for anthrax disease | | **Ebanga™** | Treatment of Zaire ebolavirus infection | | **Raxibacumab** | Treatment and prophylaxis of inhalational anthrax | | **RSDL®** | Removal/neutralization of chemical warfare agents from skin | | **TEMBEXA®** | Treatment of human smallpox disease | | **VIGIV® CNJ-016** | Treatment of complications from vaccinia vaccination | - NARCAN® (naloxone HCl) Nasal Spray received **OTC approval** on March 29, 2023, with retail shipments commencing in August 2023[33](index=33&type=chunk) - The FDA extended NARCAN® Nasal Spray's shelf-life from **36 months to 48 months** on January 18, 2024[32](index=32&type=chunk) Key Product Candidates in Development | Product Candidate | Target Indication | | :--- | :--- | | **CGRD-001** | Treatment of nerve agent/organophosphorus poisoning | | **EBS-LASV** | Prevention of Lassa fever | | **EBS-MARV** | Prevention of Marburg virus disease | | **EBS-SUDV** | Prevention of Sudan virus disease | | **Pan-Ebola mAbs** | Treatment of Ebola virus disease (Sudan virus) | | **SIAN** | Antidote for acute cyanide poisoning | | **UniFlu** | Universal influenza vaccine against influenza A and B | | **WEVEE-VLP** | Prevention of Western, Eastern, and Venezuelan equine encephalitis | [Competition](index=20&type=section&id=Competition) The company faces significant competition across its product lines, including smallpox and anthrax vaccines, NARCAN® Nasal Spray, TEMBEXA®, and its Bioservices segment - ACAM2000® vaccine faces competition from **JYNNEOS®**, licensed for both smallpox and mpox prevention[52](index=52&type=chunk) - NARCAN® Nasal Spray faces both generic competition from **Teva** and **Padagis**, and branded competition from products like Kloxxado™ and RiVive™[53](index=53&type=chunk) - TEMBEXA®, an oral antiviral for smallpox, competes with **TPOXX®** (tecovirimat), also approved for smallpox and procured by the USG[53](index=53&type=chunk) - The Bioservices segment competes with large contract manufacturers including **Lonza Group Ltd.**, **Catalent, Inc.**, and **Thermo Fisher Scientific**[56](index=56&type=chunk) [Regulation](index=23&type=section&id=Regulation) The company's operations are heavily regulated by U.S. government contracting rules and FDA requirements, with key legislation supporting MCM development and liability protection - As a U.S. Government contractor, the company is subject to extensive statutes and regulations, including the **Federal Acquisition Regulation (FAR)**[61](index=61&type=chunk) - The **Project BioShield Act** and the **Pandemic and All-Hazards Preparedness Act (PAHPA)** provide key legislative frameworks for U.S. government MCM procurement[63](index=63&type=chunk)[64](index=64&type=chunk) - The **Public Readiness and Emergency Preparedness (PREP) Act** provides liability immunity for manufacturers of designated MCMs, including smallpox, anthrax, and botulism products[67](index=67&type=chunk) - For MCMs where human efficacy trials are unethical or unfeasible, the company may seek approval under the FDA's **"Animal Rule"**, allowing efficacy data from animal studies[69](index=69&type=chunk) [Human Capital and ESG](index=36&type=section&id=Human%20Capital%20and%20ESG) In 2023, Emergent's employee count decreased due to restructuring and divestiture, while the company prioritized human capital and ESG stewardship, refreshing its materiality assessment - The company's employee base declined by approximately **900** in 2023, ending the year with around **1,600** employees, due to restructuring and the travel health business sale[112](index=112&type=chunk) - The company has three inaugural **Employee Resource Groups (ERGs)** for black, women, and veteran employees to foster communication, learning, and community engagement[116](index=116&type=chunk) - In 2023, a dedicated full-time role was created to manage ESG efforts, with the strategy influenced by **TCFD** and **SASB** frameworks[117](index=117&type=chunk)[118](index=118&type=chunk) - A 2023 materiality assessment identified top ESG priorities including **Talent Attraction, Ethics & Compliance, Product Quality & Patient Safety, Sustainable Innovation, Product Affordability & Accessibility, and Responsible Supply Chain**[120](index=120&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including heavy reliance on U.S. Government contracts, complex manufacturing compliance, intense competition for NARCAN®, significant debt, liquidity challenges, and a "going concern" qualification - The company's revenue is substantially dependent on U.S. Government procurement of key products like **CYFENDUS®**, **ACAM2000®**, and **TEMBEXA®**, with reduced demand or funding posing material harm[133](index=133&type=chunk) - Substantial doubt exists about the company's ability to continue as a **going concern** due to debt covenant non-compliance, significant debt maturing in May 2025, and the need for additional funding[276](index=276&type=chunk) - NARCAN® Nasal Spray faces significant competition from generic versions by **Teva** and **Padagis**, and other branded competitors, potentially eroding sales and revenue[232](index=232&type=chunk)[233](index=233&type=chunk) - The company has identified and is remediating **material weaknesses** in its internal control over financial reporting, which previously led to a restatement of prior period financial statements[286](index=286&type=chunk)[287](index=287&type=chunk) - Inability to maintain manufacturing compliance with **CGMP requirements** could hinder production for its own products and Bioservices customers, as evidenced by past FDA Form 483s and a warning letter[145](index=145&type=chunk) [Unresolved Staff Comments](index=89&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments - Not applicable[314](index=314&type=chunk) [Cybersecurity](index=89&type=section&id=Item%201C.%20Cyber%20Security) The company's cybersecurity program, integrated into its ERM framework, is managed by the CISO, reviewed by the board, and has not incurred material incidents in three years - Cybersecurity is one of **12 categories** in the company's Enterprise Risk Management (ERM) program, with risks assessed annually and reviewed quarterly[315](index=315&type=chunk) - The **Chief Information Security Officer (CISO)** manages cybersecurity risks and reports to the board's Quality Compliance Management Risk Committee and the full board twice annually[318](index=318&type=chunk)[320](index=320&type=chunk) - The company uses the **NIST framework** to assess third-party vendor risk and employs a **24/7 Managed Security Service Provider (MSSP)** for environmental monitoring[317](index=317&type=chunk)[320](index=320&type=chunk) - The company has not incurred material cybersecurity incidents over the past **three years** and is unaware of any reasonably likely material cybersecurity risks[320](index=320&type=chunk) [Properties](index=91&type=section&id=Item%202.%20Properties) Emergent owns and leases approximately **1.4 million square feet** across 16 locations in North America and Europe for manufacturing, labs, offices, and warehousing Principal Property Locations | Location | Use | Approx. Square Feet | Owned/Leased | | :--- | :--- | :--- | :--- | | Lansing, Michigan | Manufacturing, office, lab | 336,000 | Owned | | Winnipeg, Manitoba, Canada | Manufacturing, office, lab | 175,800 | Owned/Leased | | Gaithersburg, Maryland | Lab, office, rental | 184,547 | Owned/Leased | | Canton, Massachusetts | Manufacturing, warehouse | 149,508 | Owned/Leased | | Baltimore, Maryland (Bayview) | Manufacturing, office, lab | 112,000 | Owned | | Baltimore, Maryland (Camden) | Manufacturing, office, lab | 127,900 | Owned/Leased | [Legal Proceedings](index=91&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in multiple legal proceedings, including securities class action and shareholder derivative lawsuits, primarily related to COVID-19 vaccine manufacturing capabilities and government inquiries - The company faces a consolidated federal **securities class action lawsuit** alleging false and misleading statements about its COVID-19 vaccine bulk drug substance manufacturing capabilities[681](index=681&type=chunk) - Multiple **shareholder derivative lawsuits** have been filed against current and former officers and directors for alleged breach of fiduciary duties and waste of corporate assets related to manufacturing issues[682](index=682&type=chunk)[683](index=683&type=chunk)[684](index=684&type=chunk) - The company has received inquiries and subpoenas from the **Department of Justice**, the **SEC**, and various **state attorneys general** related to these matters, and is cooperating[685](index=685&type=chunk) [Mine Safety Disclosures](index=91&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[322](index=322&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=92&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Emergent BioSolutions Inc.'s common stock trades on the NYSE under "EBS", has not paid dividends since its 2006 IPO, and has significantly underperformed major indices over five years - The company's common stock trades on the NYSE under symbol **"EBS"**, with a closing price of **$3.20 per share** as of February 28, 2024[323](index=323&type=chunk) - The company has not declared or paid any cash dividends since its **November 2006 IPO** and has no current plans to do so[324](index=324&type=chunk) Five-Year Cumulative Total Stockholder Return | Company / Index | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Emergent BioSolutions Inc.** | **$100.00** | **$91.01** | **$151.15** | **$73.33** | **$19.92** | **$4.05** | | S&P 500 | $100.00 | $131.49 | $155.68 | $200.37 | $164.08 | $207.21 | | Russell 2000 | $100.00 | $125.52 | $150.58 | $172.90 | $137.56 | $160.85 | [Reserved](index=92&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=93&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2023, total revenues decreased to **$1.05 billion**, resulting in a **$760.5 million** net loss due to significant impairments, with the company facing a "going concern" qualification despite restructuring and divestiture efforts - The company's financial statements include a **"going concern" qualification**, indicating substantial doubt about its ability to continue operations due to debt covenant non-compliance and funding needs[422](index=422&type=chunk)[423](index=423&type=chunk) Consolidated Results of Operations (2023 vs. 2022) | (in millions) | 2023 | 2022 | | :--- | :--- | :--- | | **Total revenues** | **$1,049.3** | **$1,117.5** | | Commercial Product sales, net | $497.3 | $386.6 | | MCM product sales, net | $447.2 | $579.6 | | Services revenues | $78.5 | $109.9 | | **Loss from operations** | **($726.4)** | **($170.0)** | | Goodwill impairment | $218.2 | $6.7 | | Impairment of long-lived assets | $306.7 | $— | | **Net loss** | **($760.5)** | **($211.6)** | - In 2023, the company undertook two organizational restructuring plans, resulting in a workforce reduction of approximately **525 employees** and expected annualized savings of over **$160 million**[339](index=339&type=chunk)[345](index=345&type=chunk)[428](index=428&type=chunk) - The company sold its travel health business to Bavarian Nordic on May 15, 2023, for **$270.2 million** cash, recognizing a pre-tax gain of **$74.2 million**[340](index=340&type=chunk)[341](index=341&type=chunk) [Results of Operations (2023 vs. 2022)](index=101&type=section&id=Results%20of%20Operations%20%282023%20vs.%202022%29) In 2023, total revenues decreased **6%** to **$1.05 billion**, driven by lower MCM and Services revenues, offset by increased Commercial Product sales, leading to a **$760.5 million** net loss due to significant impairment charges - NARCAN® sales increased **30%** to **$487.5 million** in 2023, primarily driven by higher sales of NARCAN® OTC and to U.S. public interest channels[378](index=378&type=chunk) - Anthrax MCM sales decreased **35%** to **$187.6 million**, and Smallpox MCM sales decreased **29%** to **$167.4 million**, reflecting government procurement timing[382](index=382&type=chunk)[383](index=383&type=chunk) - The company recognized a **$218.2 million** goodwill impairment charge in the MCM reporting unit and a **$306.7 million** impairment charge on long-lived assets in the Bioservices unit[367](index=367&type=chunk)[368](index=368&type=chunk) - R&D expenses decreased by **41%** to **$111.4 million**, mainly due to the sale of the CHIKV VLP development program and reduced overhead from restructuring[369](index=369&type=chunk) [Results of Operations (2022 vs. 2021)](index=109&type=section&id=Results%20of%20Operations%20%282022%20vs.%202021%29) In 2022, total revenues decreased **37%** to **$1.12 billion** from **$1.77 billion** in 2021, primarily due to an **82%** drop in Services revenues, resulting in a **$211.6 million** net loss Consolidated Results of Operations (2022 vs. 2021) | (in millions) | 2022 | 2021 | | :--- | :--- | :--- | | **Total revenues** | **$1,117.5** | **$1,773.6** | | Commercial Product sales, net | $386.6 | $438.0 | | MCM product sales, net | $579.6 | $585.9 | | Services revenues | $109.9 | $615.5 | | **Income (loss) from operations** | **($170.0)** | **$341.4** | | **Net income (loss)** | **($211.6)** | **$219.5** | - Services revenues plummeted by **$505.6 million (82%)** in 2022, mainly due to the halt in manufacturing under the Janssen contract and the completion of the BARDA COVID-19 partnership[414](index=414&type=chunk)[415](index=415&type=chunk) - NARCAN® sales decreased by **14%** to **$373.7 million** in 2022, driven by lower commercial retail sales and price reductions following a generic competitor launch[406](index=406&type=chunk) [Financial Condition, Liquidity and Capital Resources](index=117&type=section&id=Financial%20Condition%2C%20Liquidity%20and%20Capital%20Resources) The company's liquidity is severely constrained, with cash dropping to **$111.7 million** and total debt at **$860.2 million**, leading to a "going concern" qualification due to debt covenant non-compliance and the need for additional funding Key Financial Position Data | (in millions) | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $111.7 | $642.6 | | Total borrowings | $860.2 | $1,405.8 | | Total working capital | $28.2 | ($18.5) | - The company was not in compliance with its minimum consolidated EBITDA covenant as of December 31, 2023, leading to a **Forbearance Agreement** from lenders until April 30, 2024[425](index=425&type=chunk) Cash Flow Summary (2023) | (in millions) | 2023 | | :--- | :--- | | Net cash used in operating activities | ($206.3) | | Net cash provided by investing activities | $212.3 | | Net cash used in financing activities | ($535.7) | - As of December 31, 2023, the company has approximately **$526.9 million** in non-cancelable purchase commitments for raw materials and Bioservices over the next five years[673](index=673&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=128&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from interest rates and foreign currency exchange rates, with a **1%** eurocurrency rate increase impacting annual interest expense by approximately **$4.2 million** - The company has floating rate debt, and a hypothetical **1%** increase in the eurocurrency rate would increase annual interest expense by approximately **$4.2 million**[463](index=463&type=chunk) - The company is exposed to foreign currency exchange rate fluctuations, primarily with respect to the **Euro**, **Canadian dollar**, **Swiss franc**, and **British pound**[464](index=464&type=chunk) - The company terminated its interest rate swap agreements in June 2023 and is currently satisfied with its mix of fixed and floating rate debt[462](index=462&type=chunk) [Financial Statements and Supplementary Data](index=129&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The audited consolidated financial statements for 2023 show significant financial deterioration, with total assets decreasing to **$1.82 billion**, a net loss of **$760.5 million**, and an auditor's "going concern" qualification - The Report of Independent Registered Public Accounting Firm includes an explanatory paragraph stating substantial doubt exists about the Company's ability to continue as a **going concern**[472](index=472&type=chunk) Consolidated Balance Sheet Highlights | (in millions) | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **$1,823.2** | **$3,166.3** | | Cash and cash equivalents | $111.7 | $642.6 | | Property, plant and equipment, net | $382.8 | $817.6 | | Goodwill | $— | $218.2 | | **Total Liabilities** | **$1,173.9** | **$1,778.6** | | Debt, current portion | $413.7 | $957.3 | | **Total Stockholders' Equity** | **$649.3** | **$1,387.7** | Consolidated Statement of Operations Highlights | (in millions, except per share) | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | **Total revenues** | **$1,049.3** | **$1,117.5** | **$1,773.6** | | **Income (loss) from operations** | **($726.4)** | **($170.0)** | **$341.4** | | **Net income (loss)** | **($760.5)** | **($211.6)** | **$219.5** | | **Diluted net income (loss) per share** | **($14.85)** | **($4.22)** | **$4.06** | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=191&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item is not applicable - Not applicable[687](index=687&type=chunk) [Controls and Procedures](index=191&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2023, management concluded the company's disclosure controls and internal control over financial reporting were effective, with a previously identified material weakness remediated - Management concluded that as of December 31, 2023, the company's disclosure controls and procedures were **effective**[688](index=688&type=chunk) - Management concluded that as of December 31, 2023, the company's internal control over financial reporting was **effective**, and the independent auditor issued an **unqualified opinion**[690](index=690&type=chunk)[691](index=691&type=chunk)[696](index=696&type=chunk) - A material weakness related to state deferred tax calculations, identified in Q3 2023, was **remediated** as of December 31, 2023[692](index=692&type=chunk)[693](index=693&type=chunk) [Other Information](index=194&type=section&id=Item%209B.%20Other%20Information) During Q4 2023, no directors or Section 16 reporting officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - During the three months ended December 31, 2023, none of the Company's directors or Section 16 reporting officers adopted or terminated any **Rule 10b5-1** or **non-Rule 10b5-1 trading arrangement**[703](index=703&type=chunk) [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=194&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20That%20Prevent%20Inspections) This item is not applicable - Not applicable[704](index=704&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=194&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the company's 2024 Annual Meeting of Stockholders proxy statement - The company has adopted a **code of business conduct and ethics** applicable to all directors, officers, and employees, available on its website[705](index=705&type=chunk) - The required information for this item is incorporated by reference from the company's **2024 proxy statement**[706](index=706&type=chunk) [Executive Compensation](index=194&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's 2024 Annual Meeting of Stockholders proxy statement - The required information for this item is incorporated by reference from the company's **2024 proxy statement**[707](index=707&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=194&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of beneficial owners, management, and related stockholder matters is incorporated by reference from the company's 2024 Annual Meeting of Stockholders proxy statement - The required information for this item is incorporated by reference from the company's **2024 proxy statement**[708](index=708&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=194&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's 2024 Annual Meeting of Stockholders proxy statement - The required information for this item is incorporated by reference from the company's **2024 proxy statement**[709](index=709&type=chunk) [Principal Accountant Fees and Services](index=194&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the company's 2024 Annual Meeting of Stockholders proxy statement - The required information for this item is incorporated by reference from the company's **2024 proxy statement**[710](index=710&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=195&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements, schedules, and exhibits filed as part of the Annual Report on Form 10-K, including consolidated financial statements and a comprehensive exhibit index - This section contains the list of financial statements and **Schedule II - Valuation and Qualifying Accounts** filed with the report[712](index=712&type=chunk)[713](index=713&type=chunk) - A detailed **Exhibit Index** lists all required documents filed by Item 601 of Regulation S-K, including corporate governance documents, material contracts, and certifications[714](index=714&type=chunk)[718](index=718&type=chunk) [Form 10-K Summary](index=202&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable - Not applicable[727](index=727&type=chunk)

Financial Data and Key Metrics Changes - Emergent reported total revenues of $277 million for the fourth quarter, with full-year revenue of $1.05 billion, aligning with the midpoint of previously provided guidance [58][61] - Adjusted EBITDA for the fourth quarter was $3.4 million, while the full-year adjusted EBITDA was negative $22 million, indicating challenges in profitability [58][61] - The company ended 2023 with $112 million in cash and a net debt position of $757 million, reflecting ongoing efforts to improve financial stability [45][61] Business Line Data and Key Metrics Changes - NARCAN sales reached $111 million in the fourth quarter, driven by strong demand from the U.S. public interest channel and the launch of OTC NARCAN [40][58] - The Commercial Products segment generated $111 million in revenue, entirely from NARCAN, with a segment adjusted gross margin of 55% [43] - The MCM Products segment reported revenues of $138 million, influenced by anthrax and other medical countermeasure products, with a segment adjusted gross margin of 30% [43][44] Market Data and Key Metrics Changes - The opioid crisis remains a significant public health issue, with 105,000 overdose deaths reported in the last year, emphasizing the importance of NARCAN [30] - Emergent's NARCAN Direct distribution platform facilitated the distribution of approximately 22 million doses in the U.S. and Canada [31] Company Strategy and Development Direction - The company is focused on a multiyear plan to stabilize, turn around, and transform its operations, with an emphasis on reducing debt and improving financial performance [8][9] - A strategic shift towards enhancing the NARCAN product line and expanding access through various channels, including retail and business-to-business markets, is underway [16][24][77] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by debt and emphasized the importance of improving operational performance and reducing working capital [23][24] - The company anticipates variability in its 2024 forecast due to changing government procurement dynamics and funding levels [55][63] Other Important Information - Emergent has entered into a forbearance agreement with lenders through April 30, 2024, as part of its debt reduction strategy [9][53] - The company achieved significant contract wins, including a $379.6 million contract with the U.S. Department of Defense, reinforcing its role in public health preparedness [37][38] Q&A Session Summary Question: What are the product or asset sales you are considering? - Management indicated that they are evaluating various opportunities to reduce debt, including potential product and asset sales, but specifics were not disclosed [70][75] Question: Can you talk about the MCM guidance, particularly regarding ACAM2000 and TEMBEXA? - Management expects additional procurement for ACAM2000 in mid-2024, while TEMBEXA procurement has been deferred [78][79] Question: How does the OTC designation for NARCAN impact its availability? - The OTC designation is expected to expand access across all channels, with strong federal and state support for public interest segments [77][91] Question: What is the impact of the sBLA for ACAM2000 on future sales? - A positive FDA response to the sBLA could enhance sales potential for ACAM2000 in 2025 and beyond, but no immediate contributions are expected in 2024 [83] Question: Can you provide details on the public interest channel for NARCAN? - The public interest channel aims to distribute NARCAN to vulnerable populations, with ongoing efforts to increase access through various initiatives [84][86]