Emergent BioSolutions Reports Third Quarter 2024 Financial Results

Third Quarter 2024 Total Revenues of $293.8 million, increase of 9% versus prior year

Third Quarter 2024 Net Income of $114.8 million, increase of 144% versus prior year

Third Quarter 2024 Adjusted EBITDA of $105.3 million, increase of 432% versus prior year

Raises FY 2024 guidance

GAITHERSBURG, Md., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today reported financial results for the third quarter ended September 30, 2024.

"Through disciplined execution and steady, measurable progress, Emergent's financial position is the strongest it has been since 2021 as evidenced by our favorable third-quarter results," said CEO Joe Papa. "We have successfully improved efficiencies and refocused our operations related to customer demand, generated value in our core medical countermeasures and NARCAN® Nasal Spray businesses and refinanced our debt leading to increased revenue and cash flow."

Papa continued, "Based on the success of our efforts since the beginning of this year, we are officially entering the turnaround phase of our multi-year transformation plan, and we will be focused on driving profitable growth, continued operational improvements and the generation of sustainable value for shareholders. We believe ongoing public health crises like the opioid overdose epidemic and mpox outbreak underscore the need for Emergent's capabilities and expertise. It is not if, but when, the next public health threat emerges, and we believe we are uniquely qualified to help respond to protect, enhance and save lives."

FINANCIAL HIGHLIGHTS(1)

Year to Date (“YTD”) 2024 vs. YTD 2023

SELECT Q3 2024 BUSINESS UPDATES

Secured a new Term Loan for $250 million with OHA Agency, LLC as administrative agent.

Closed on a new asset backed loan facility for $100 million with Wells Fargo Bank, National Association.

Received $75 million for the sale of our RSDL® (Reactive Skin Decontamination Lotion) product to a subsidiary of SERB Pharmaceuticals ("SERB"), subject to customary adjustments based on inventory value at closing

Completed the sale of the Baltimore-Camden manufacturing site for $35 million, including customary post-closing adjustments

Sold an underutilized warehouse at our Canton, MA facility for $7 million

Received $50 million in the third quarter related to the resolution of the contractual dispute with Janssen Pharmaceuticals, Inc.

Earned $30 million development milestone payments from Bavarian Nordic as part of the sale of the Travel Health Business

THIRD QUARTER 2024 FINANCIAL PERFORMANCE(1)

The Company uses the following categories in discussing product/service level revenues:

NARCAN® — comprises contributions from NARCAN® Nasal Spray

Anthrax MCM — comprises contributions from CYFENDUS®, previously known as AV7909, BioThrax®, Anthrasil® and Raxibacumab

Smallpox MCM — comprises contributions from ACAM2000®, VIGIV and TEMBEXA®

Other Products — comprises contributions from BAT® and RSDL®

Bioservices — comprises service and lease revenues from the Bioservices business

For Q3 2024, revenues from NARCAN® (naloxone HCl) Nasal Spray decreased $46.8 million, or 33%, as compared with Q3 2023. The decrease was primarily driven by the discontinuation of prescription NARCAN® due to the launch of over-the-counter (“OTC”) NARCAN® in the third quarter of 2023 and lower Canadian retail sales, partially offset by higher sales of OTC NARCAN®.

For Q3 2024, revenues from Anthrax MCM products decreased $21.5 million, or 65%, as compared with Q3 2023. The decrease reflects the impact of timing of sales related to CYFENDUS® and Anthrasil®, partially offset by an increase in BioThrax® sales, due to timing. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the U.S. government (the “USG”). Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and the Company’s delivery of orders that follow.

For Q3 2024, revenues from Smallpox MCM products increased $108.0 million, or 437%, as compared with Q3 2023. The increase was primarily due to timing of USG purchases of ACAM2000® and VIGIV. Fluctuations in revenues from Smallpox MCM result from the timing of the exercise of annual purchase options in the existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow.

For Q3 2024, revenues from Other Product sales decreased $20.0 million, or 40%, as compared with Q3 2023. The decrease was due to lower product sales of BAT®, due to timing of deliveries, and lower product sales of RSDL®, which was sold to SERB during the third quarter of 2024.

Bioservices Revenues

For Q3 2024, revenues from Bioservices services increased $0.7 million, or 5%, as compared with Q3 2023. The increase was primarily attributable to an increase in production at the Company’s Camden facility, prior to the sale of the facility to Bora, partially offset by lower production at the Company’s Canton and Winnipeg facilities.

For Q3 2024, revenues from Bioservices leases decreased $0.6 million, or 60%, as compared with Q3 2023. The decrease was related to the completion of a lease for a Bioservices customer at our Canton facility, partially offset by new lease revenue associated with SERB at our Winnipeg facility.

Contracts and Grants

For Q3 2024, revenues from contracts and grants increased $3.5 million, or 54%, as compared with Q3 2023. The increase was primarily due to timing of funding as well as an increase related to work under the Ebanga™ program.

Cost of Commercial Product Sales

For Q3 2024, cost of Commercial Product sales decreased $12.8 million, or 21%, as compared with Q3 2023. The decrease was primarily due to lower prescription NARCAN® unit volume, partially offset by higher OTC NARCAN® unit volume.

Cost of MCM Product Sales

For Q3 2024, cost of MCM Product sales decreased $18.5 million, or 26%, as compared with Q3 2023. The decrease was primarily due to lower sales of BAT® and CYFENDUS®, coupled with lower allocations to Cost of MCM Product sales at our Bayview facility. This decrease was partially offset by higher sales of BioThrax® and ACAM2000®.

For Q3 2024, cost of Bioservices decreased $22.9 million, or 52%, as compared with Q3 2023. The decrease was primarily due to lower overhead and remediation costs related to the sale of the Camden facility, coupled with a decrease in overhead costs at our other Maryland facilities as a result of the announced shutdowns and lower costs at our Canton facility. The decrease was partially offset by an increase in production at our Winnipeg facility.

Research and Development Expenses

For Q3 2024, R&D expenses decreased $1.5 million, or 10%, as compared with Q3 2023. The decrease was driven by a reduction in spend for certain funded and unfunded projects, excluding Ebanga™. The decrease was partially offset by an increase in funded R&D related to Ebanga™.

Selling, General and Administrative Expenses

For Q3 2024, SG&A expenses decreased $9.4 million, or 11%, as compared with Q3 2023. The decrease was primarily due to lower employee related expenses and compensation as a result of restructuring initiatives during 2023 and 2024, coupled with a decrease in legal services fees for disputes and other corporate initiatives. This decrease was partially offset by the settlement charge related to the stockholder litigation matter, net of expected insurance proceeds.

For Q3 2024, Goodwill impairment decreased $218.2 million as compared with Q3 2023. The decrease was due to the Q3 2023 non-cash impairment charge to Goodwill in the MCM Products reporting unit, which reduced the reporting unit’s goodwill balance to zero.

ADDITIONAL FINANCIAL INFORMATION(1)

Capital Expenditures

For Q3 2024, capital expenditures decreased largely due to lower product development activities across the Company’s facilities.

The Company manages the business with a focus on three reportable segments: (1) the Commercial Products segment consisting of our NARCAN® and other commercial products that were sold as part of our travel health business in the second quarter of 2023; (2) the MCM Products segment consisting of the Anthrax - MCM, Smallpox - MCM and Other products and (3) the services segment (“Services”) consisting of our Bioservices business. The Company evaluates the performance of these reportable segments based on revenues and segment adjusted gross margin, which is a non-GAAP financial measure. Segment revenue includes external customer sales, but does not include inter-segment services. The Company does not allocate contracts and grants revenue, R&D, SG&A, amortization of intangible assets, interest and other income (expense) or taxes to its evaluation of the performance of these segments.

THIRD QUARTER 2024 SEGMENT RESULTS

Commercial Products gross margin decreased $34.0 million, or 41%, to $48.1 million in the quarter, as compared with $82.1 million in the prior year quarter. Commercial Products gross margin percentage decreased seven percentage points to 50% for the quarter ended September 30, 2024. The decrease was largely due to an unfavorable price and volume mix in 2024 for NARCAN® products. Commercial Products segment adjusted gross margin is consistent with gross margin.

MCM Products gross margin increased $85.0 million, or 241%, to $120.2 million in the quarter, as compared with $35.2 million in the prior year quarter. MCM Products gross margin percentage increased 36 percentage points to 69% for the quarter ended September 30, 2024. The increase was largely due to overall higher sales volumes with a favorable product mix weighted more heavily to higher margin products coupled with lower allocations to cost of MCM Product sales at our Bayview facility and overall lower shutdown and overhead costs across our facilities. MCM Product segment adjusted gross margin in the current year period excludes the impact of non-cash items related to the impact of restructuring costs of $4.9 million and inventory step-up provision of $1.2 million.

Services gross margin increased $23.0 million, or 76%, to $(7.1) million in the quarter, as compared with $(30.1) million in the prior year quarter. Services gross margin percentage increased 162 percentage points to (50)% for the quarter ended September 30, 2024. The increase was primarily due to lower overhead and remediation costs related to the sale of the Camden facility coupled with lower costs at our Bayview facility. Services segment adjusted gross margin in the current year period excludes the impact of restructuring costs of $0.1 million.

YTD 2024 SEGMENT RESULTS

Commercial Products gross margin decreased $44.9 million, or 20%, to $181.1 million for the nine months ended September 30, 2024, as compared with $226.0 million for the nine months ended September 30, 2023. Commercial Products gross margin percentage decreased five percentage points to 54% in 2024. The decrease was largely due to an unfavorable price and volume mix in 2024 for NARCAN® products, partially offset by the sale of the products associated with our travel health business to Bavarian Nordic. Commercial Products segment adjusted gross margin is consistent with gross margin.

MCM Products gross margin increased $144.9 million, or 144%, to $245.7 million for the nine months ended September 30, 2024, as compared with $100.8 million for the nine months ended September 30, 2023. MCM Products gross margin percentage increased 29 percentage points to 63% for the nine months ended September 30, 2024. The increase was largely due to overall higher sales volumes with a favorable product mix weighted more heavily to higher margin products coupled with lower allocations to Cost of MCM Product sales at our Bayview facility and lower shutdown related costs, a reduction in Trobigard® related costs, due to the Trobigard® revocation, and realization of previously adjusted inventory values. MCM Product segment adjusted gross margin excludes the impact of restructuring costs of $7.5 million, inventory step-up provision of $1.2 million and changes in fair value of financial instruments of $0.6 million.

Services gross margin decreased $71.8 million, or 76%, to $(165.8) million for the nine months ended September 30, 2024, as compared with $(94.0) million for the nine months ended September 30, 2023. Services gross margin percentage decreased 7 percentage points to (170)% for the nine months ended September 30, 2024. The decrease was primarily due to the Settlement Agreement with Janssen and resulting revenue and write-down of related assets to net realizable value, coupled with lower production at the Company's Canton facility. This decrease was partially offset by an increase in production at the Camden facility prior to the sale of the facility to Bora and a decrease in overhead costs at our other Maryland facilities. Services segment adjusted gross margin in the current year period excludes the impact of segment settlement charge, net of $110.2 million and restructuring costs of $0.3 million.

2024 FINANCIAL FORECAST

The Company provides the following updated financial forecast for full year 2024, reflecting management's expectations based on the most current information available.

(1) All financial information included in this release is unaudited.

(2) See “Non-GAAP Financial Measures” and the "Reconciliation of Non-GAAP Financial Measures" tables for the definitions and reconciliations of these non-GAAP financial measures to the most closely related GAAP financial measures.

(3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts in accordance with U.S. generally accepted accounting principles.

(4) Our Commercial Products forecast consists solely of NARCAN® Nasal Spray, as our Other Commercial Products, including Vivotif® and Vaxchora®, were sold to Bavarian Nordic as part of our travel health business in May 2023.

(5) Our Services revenue forecast includes $50.0 million related to the Settlement Agreement with Janssen and excludes revenues related to the Baltimore-Camden Facility after August 20, 2024.

CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm eastern time today, November 6, 2024, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company's website or through the following:

To join via telephone, please use the following dial-in details:

U.S. / New York: +1-646-968-2525

U.S. & Canada (Toll Free): +1-888-596-4144

Conference ID: 5259189

Visit https://edge.media-server.com/mmc/p/nm3oj8g9

A replay of the call can be accessed from the Emergent website.

ABOUT EMERGENT BIOSOLUTIONS INC.

NON-GAAP FINANCIAL MEASURES

In the accompanying analysis of financial information, we sometimes use information derived from consolidated and segment financial information that may not be presented in our financial statements or prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Certain of these financial measures are considered not in conformity with GAAP (“non-GAAP financial measures”) under the United States Securities and Exchange Commission (“SEC”) rules. Specifically, we have referred to the following non-GAAP financial measures:

Adjusted Net Income (Loss)

Adjusted Net Income (Loss) per Diluted Share

Total Segment Revenues

Total Segment Gross Margin

Total Segment Gross Margin %

Total Segment Adjusted Gross Margin

Total Segment Adjusted Gross Margin %

Segment Adjusted Gross Margin

Segment Adjusted Gross Margin %

We define Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per Diluted Share, which are non-GAAP financial measures, as net income (loss) and net income (loss) per diluted share, respectively, excluding the impact of changes in fair value of financial instruments, acquisition and divestiture-related costs, severance and restructuring costs, settlement charges, net, exit and disposal costs, impairment charges, gain (loss) on sale of business, non-cash amortization charges, contingent consideration milestones, and other income (expense) items. We use Adjusted Net Income (Loss) for the purpose of calculating Adjusted Net Income (Loss) per Diluted Share. Management uses Adjusted Net Income (Loss) per Diluted Share to assess total Company operating performance on a consistent basis. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results and GAAP financial measures, provide management and investors with an additional understanding of our business operating results, including underlying trends.

We define Adjusted EBITDA, which is a non-GAAP financial measure, as consolidated net income (loss) before income tax provision (benefit), interest expense, net, depreciation, amortization of intangible assets, excluding the impact of changes in fair value of financial instruments, acquisition and divestiture-related costs, severance and restructuring costs, settlement charges, net, exit and disposal costs, impairment charges, gain (loss) on sale of business, non-cash amortization charges, contingent consideration milestones and other income (expense) items. We believe that this non-GAAP financial measure, when considered together with our GAAP financial results and GAAP financial measures, provides management and investors with a more complete understanding of our operating results, including underlying trends. In addition, EBITDA is a common alternative measure of operating performance used by many of our competitors. It is used by investors, financial analysts, rating agencies and others to value and compare the financial performance of companies in our industry, although it may be defined differently by different companies. Therefore, we also believe that this non-GAAP financial measure, considered along with corresponding GAAP financial measures, provides management and investors with additional information for comparison of our operating results with the operating results of other companies.

We have included the definitions of Segment Gross Margin and Segment Gross Margin %, which are GAAP financial measures, below in order to more fully define the components of certain non-GAAP financial measures presented in this press release. We define Segment Gross Margin, as a segment's revenues, less a segment's cost of sales or services. We define Segment Gross Margin %, as Segment Gross Margin as a percentage of a segments revenues. We define Segment Adjusted Gross Margin, which is a non-GAAP financial measure as Segment Gross Margin excluding the impact of restructuring costs, changes in the fair value of financial instruments, settlement charges, net and inventory step-up provision. We define Segment Adjusted Gross Margin %, which is a non-GAAP financial measure, as Segment Adjusted Gross Margin as a percentage of a segment's revenues.

We define Total Segment Revenues, which is a non-GAAP financial measure, as our Total Revenues, less contracts and grants revenue, which is also equal to the sum of the revenues of our reportable operating segments. We define Total Segment Gross Margin, which is a non-GAAP financial measure, as Total Segment Revenues less our aggregate cost of sales or services. We define Total Segment Gross Margin %, which is a non-GAAP financial measure, as Total Segment Gross Margin as a percentage of Total Segment Revenues. We define Total Segment Adjusted Gross Margin, which is a non-GAAP financial measure, as Total Segment Gross Margin, excluding the impact of restructuring costs, settlement charges, net, changes in the fair value of financial instruments and inventory step-up provision. We define Total Segment Adjusted Gross Margin %, which is a non-GAAP financial measure, as Total Segment Adjusted Gross Margin as a percentage of Total Segment Revenues.

Non-GAAP financial measures are not defined in the same manner by all companies and may not be comparable with other similarly titled measures of other companies. The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Non-GAAP financial measures should be considered in addition to, but not as a substitute for or superior to, the information contained in our Consolidated Statements of Operations and Consolidated Statements of Cash Flows. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial tables accompanying this press release.