• Reports record fourth quarter and year to date 2020 performance, in line with prior guidance
    • Reaffirms full year 2021 forecast

    GAITHERSBURG, Md., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today reported financial results for the quarter and year ended December 31, 2020. The Company also reaffirmed its full year 2021 forecast.

    "Emergent's financial and operational performance in 2020 reflects the impact we are making in addressing the growing public health threat landscape and meeting our mission to protect and enhance the lives of patients," said Robert G. Kramer, president and CEO of Emergent BioSolutions. "We look forward to continuing to execute on our strategy with vaccines, therapeutics, devices…

    • Reports record fourth quarter and year to date 2020 performance, in line with prior guidance
    • Reaffirms full year 2021 forecast

    GAITHERSBURG, Md., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today reported financial results for the quarter and year ended December 31, 2020. The Company also reaffirmed its full year 2021 forecast.

    "Emergent's financial and operational performance in 2020 reflects the impact we are making in addressing the growing public health threat landscape and meeting our mission to protect and enhance the lives of patients," said Robert G. Kramer, president and CEO of Emergent BioSolutions. "We look forward to continuing to execute on our strategy with vaccines, therapeutics, devices, and contract development and manufacturing services. Our strong core business, robust development pipeline, and innovator and public-private partnership opportunities position us to remain leaders in the market and create long-term shareholder value."

    FINANCIAL HIGHLIGHTS (1)

    (in millions, except per share data)Q4 2020Q4 2019% Change
    Total Revenues$583.0$360.462%
    Net Income$185.4$46.9*
    Net Income Per Diluted Share$3.44$0.90*
    Adjusted Net Income (2)$198.8$82.7*
    Adjusted Net Income Per Diluted Share (2)$3.67$1.57*
    Adjusted EBITDA (2)$290.9$134.3*
          



    (in millions, except per share data)Full Year 2020Full Year 2019% Change
    Total Revenues$1,555.4$1,106.041%
    Net Income$305.1$54.5*
    Net Income Per Diluted Share$5.67$1.04*
    Adjusted Net Income (2)$423.9$152.3*
    Adjusted Net Income Per Diluted Share (2)$7.88$2.91*
    Adjusted EBITDA (2)$630.4$279.7*
    * % change greater than 100%
     

    SELECT Q4 2020 AND RECENT BUSINESS ACCOMPLISHMENTS

    • Completed three-year, $50 million expansion at the Company's Baltimore Camden drug product facility, including a new state-of-the-art fill/finish line that became operational in January 2021, intended to significantly increase contract development and manufacturing (CDMO) capacity and capability.
    • Signed a CDMO services agreement with Providence Therapeutics to provide drug product manufacturing services for their mRNA PTX-COVID19-B vaccine candidate at the Company's Winnipeg, Manitoba facility.
    • Signed a CDMO services agreement for drug product manufacturing of Humanigen's COVID-19 therapeutic candidate, lenzilumab™, at the Company's Baltimore Camden facility.
    • Initiated a Phase 3 clinical trial with the National Institutes of Health to evaluate hyperimmune globulins, including the Company's COVID-19 human hyperimmune globulin (COVID-HIG) product candidate, as a potential treatment in adult patients hospitalized with COVID-19.
    • Initiated a clinical program to evaluate COVID-HIG to support its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2 such as front-line health care workers and military personnel.

    2020 FINANCIAL PERFORMANCE (1)

    (I) Quarter Ended December 31, 2020

    Revenues

    Total Revenues

    For Q4 2020, total revenues were $583.0 million, an increase of 62% over the same period in Q4 2019, primarily driven by increased contract development and manufacturing (CDMO) services revenues.

    Product Sales

    For Q4 2020, total product sales were $340.9 million, an increase of $30.1 million or 10% as compared to Q4 2019. Other product sales decreased due to a decline in sales of raxibacumab, VIGIV [Vaccinia Immune Globulin Intravenous (Human)] and the Company's travel health vaccines, partially offset by increased sales of BAT®[Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)].

     Three Months Ended December 31,
    (in millions)20202019% Change
    Product Sales:      
    ACAM2000®$129.3$78.565%
    Anthrax Vaccines$115.7$92.925%
    NARCAN® Nasal Spray$77.4$66.916%
    Other$18.5$72.5(74)%
    Total Product Sales$340.9$310.810%
           

    Contract Development and Manufacturing (CDMO) Services

    For Q4 2020, revenue from CDMO services was $199.1 million, an increase of $173.6 million as compared to Q4 2019. The increase is largely due to the contribution for services performed to address the COVID-19 pandemic provided to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers across Development Services, Drug Substance manufacturing, and Drug Product manufacturing and Packaging.

    Contracts and Grants

    For Q4 2020, revenue from development-based contracts and grants was $43.0 million, an increase of $18.9 million or 78% as compared to Q4 2019. The increase primarily reflects the contribution from development awards related to the Company's COVID-HIG product candidate, partially offset by a decrease in  contribution associated with development activities from the Company's AV7909 (Anthrax Vaccine Adsorbed, adjuvanted) product candidate, reflecting the advanced stage of development for the program.

    Operating Expenses

    Cost of Product Sales and Contract Development and Manufacturing (CDMO) Services

    For Q4 2020, cost of product sales and CDMO services was $168.3 million, an increase of $35.5 million or 27% as compared to Q4 2019. Cost of product sales and CDMO services includes the impact of contingent consideration charges, which declined $12 million in Q4 2020 compared to Q4 2019. Excluding the impacts of the contingent consideration charges between periods, the cost of product sales and CDMO services increased $47.5 million. This increase is primarily due to an increase in CDMO services and product sale activities in Q4 2020 as compared to Q4 2019.

    Research and Development (Gross and Net) (2)

    For Q4 2020, gross R&D expenses were $59.5 million, a decrease of $3.3 million or 5% as compared to Q4 2019. The decrease primarily reflects the impact of the impairment of the IPR&D intangible asset in Q4 2019 that did not recur in Q4 2020, offset by increased costs associated with the Company's COVID-19 product candidates.

    For Q4 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners, was $16.5 million, a decrease of $10.2 million or 38% as compared to Q4 2019. The decrease is attributable to a reduction in R&D activities at the Company's Bayview facility in 2020 compared to 2019 as the facility was principally used for CDMO services in 2020. The Q4 2020 and Q4 2019 net R&D expense was 3% and 8% of adjusted revenue, respectively.

    Selling, General and Administrative

    For Q4 2020, selling, general and administrative expenses were $82.1 million, an increase of $9.9 million or 14% as compared to Q4 2019. The increase primarily reflects an increase in staffing costs to support the Company's growth.

    Additional Financial Information

    Gross Margin (2)

    For Q4 2020, gross margin was $371.7 million or 69% of adjusted revenue, an increase of $168.2 million or 8% as compared to Q4 2019. For Q4 2020, adjusted gross margin was $370.6 million or 69% of adjusted revenue, an increase of $154.7 million or 4% as compared to Q4 2019. The improvement reflects the impact of product mix as well as improved contribution from CDMO services.

    CDMO Backlog and Opportunity Funnel

    CDMO backlog, defined as estimated future services revenues for 2021 and beyond under signed contracts, was $1.34 billion at December 31, 2020, reflecting the impact of additional services on existing contracts and newly awarded contracts of $53.3 million during the quarter offset by revenue recognized to date on contracted amounts.

    The CDMO opportunity funnel, defined as the initial contract value to potentially be realized in 2021 and beyond based on issued proposals as well as the value of extensions associated with existing contracts, was approximately $689 million as of December 31, 2020. This amount reflects the increased traction resulting from ongoing sales and business development and marketing efforts domestically and internationally to existing and new pharmaceutical and biotechnology innovators as well as government/NGO customers, and excludes the potential value of extensions of contracts with Johnson & Johnson and AstraZeneca.

    (II) Full Year 2020

    Revenues

    Total Revenues

    For the full year 2020, total revenues were $1,555.4 million, an increase of 41% over 2019. Total revenues largely reflect an increase in contract development and manufacturing services revenues as well as product sales.

    Product Sales

    For the full year 2020, product sales were $989.8 million, an increase of $86.3 million or 10% as compared to 2019. Other product sales decreased due to a decline in sales of raxibacumab and travel health vaccines.

     Year Ended December 31,
    (in millions)20202019% Change
    Product Sales:
    Anthrax Vaccines$373.8$172.8*
    NARCAN® Nasal Spray$311.2$280.411%
    ACAM2000®$200.3$242.6(17)%
    Other$104.5$207.7(50)%
    Total Product Sales$989.8$903.510%
           

    Contract Development and Manufacturing (CDMO) Services

    For the full year 2020, revenue from CDMO services was $450.5 million, an increase of $370.5 million as compared to 2019. The increase is largely due to the contribution for services performed to address the COVID-19 pandemic provided to pharmaceutical and biotechnology innovators and government/NGO customers across Development Services, Drug Substance manufacturing, and Drug Product manufacturing and Packaging.

    Contracts and Grants

    For the full year 2020, revenue from development-based contracts and grants was $115.1 million, a decrease of $7.4 million or 6% as compared to 2019. The decrease primarily reflects  the  completion  of  development  activities associated with the AV7909 product candidate in 2019, offset by recent new development awards related to the Company's COVID-19 product candidates and other product candidates.

    Operating Expenses

    Cost of Product Sales and Contract Development and Manufacturing Services

    For the full year 2020, cost of product sales and CDMO services was $524.0 million, an increase of $90.5 million or 21% as compared to 2019. The increase is due primarily to an increase in volume of product sales and CDMO services, charges related to the Company's contingent consideration liabilities, and a write-down of inventory for the Company's travel health vaccines.

    Research and Development (Gross and Net) (2)

    For the full year 2020, gross R&D expenses were $234.5 million, an increase of $8.3 million or 4% compared to 2019. The increase primarily reflects the impact of impairment of the Company's IPR&D intangible asset of $29.0 million in 2020 as compared to $12.0 million in 2019. Excluding these items, gross R&D expense decreased $8.7 million compared to 2019. The decrease primarily reflects lower costs associated with the Company's AV7909 product candidate, reflecting the advanced-stage of its development, offset by increased costs associated with the Company's COVID-19 product candidates.

    For the full year 2020, net R&D expense was $90.4 million, a decrease of $1.3 million or 1% as compared to 2019. The decrease primarily reflects a decline in spending associated with the Company's FLU-IGIV and CHIKV VLP product candidates and the change in the nature of operations from primarily R&D to commercial CDMO manufacturing at the Company's Bayview facility, offset by an increase in costs associated with the Company's COVID-19 and other product candidates. The 2020 and 2019 net R&D expense as a percentage of adjusted revenues was 6% and 9%, respectively.

    Selling, General and Administrative

    For the full year 2020, selling, general and administrative expenses were $303.3 million, an increase of $29.8 million or 11% as compared to 2019. The increase primarily reflects an increase in staffing costs to support the Company's growth as well as an increase in share-based compensation due to a special broad-based, immediately vested equity award to employees.

    Additional Financial Information

    Gross Margin (2)

    For the full year 2020, gross margin was $916.3 million or 64% of adjusted revenue, an increase of $366.3 million or 8% as compared to 2019. For the full year 2020, adjusted gross margin was $960.6 million or 67% of adjusted revenue, an increase of $385.8 million or 8% as compared to 2019. The improvement reflects the impact of product mix as well as improved contribution from CDMO services.

    Operating Cash Flow

    For the full year 2020, operating cash flow was $536.0 million, an increase of $348.0 million as compared to 2019. The increase reflects the cash generating strength of the Company's current diversified mix of product sales and CDMO services.

    Capital Expenditures

    For the full year 2020, capital expenditures were $141.0 million, an increase of $54.1 million or 62% as compared to 2019. Expressed as a percentage of total revenues, capital expenditures for the full year 2020 was 9%, versus 8% in 2019. The 2020 figure reflects investments in key areas of the Company's operations, including technology, and capacity and capability expansions in service of the CDMO business. In 2020, the company was reimbursed for $41.8 million of capital expenditures pursuant to third-party funding arrangements, resulting in capital expenditures net of reimbursement of $99.2 million.

    2021 FINANCIAL FORECAST

    For full year 2021, the Company reaffirms its forecast of the following financial metrics, originally announced on January 10, 2021:

    (in millions)2021 Forecast (As of 2/18/2021)
    Total Revenues$1,950 - $2,050
    •           NARCAN® Nasal Spray$305 - $325
    •           Anthrax Vaccines$280 - $310
    •           ACAM2000®$185 - $205
    •           CDMO$925 - $965
    Adjusted EBITDA (2)$750 - $810
    Adjusted Net Income (2)$475 - $525
    Gross Margin (2)65%
      

    The Company's financial forecast for 2021 includes the following additional considerations:

    • Anthrax vaccine revenues are expected at a more normalized annual level and continue to primarily reflect procurement of AV7909 (Anthrax Vaccine Adsorbed, adjuvanted) under the Company's existing contract with the Biomedical Advanced Research and Development Authority (BARDA).
    • ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) vaccine deliveries are expected to continue under the terms of the Company's existing contract with the U.S. Department of Health and Human Services (HHS) at unit volume levels consistent with 2020 deliveries.
    • Narcan® (naloxone HCl) Nasal Spray revenues assume an appellate decision related to its pending patent litigation in the second half of 2021 followed by the entry of at least one competitor.
    • CDMO Services assume continued performance of contracted services for Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers.
    • Pipeline progress is expected across the vaccines, therapeutics, and devices portfolios, anticipating at least one Phase 3 launch and one Biologics License Application (BLA)/Emergency Use Authorization (EUA) filing.
    • Capital expenditures, net of reimbursement, are expected to be in a range of 8% to 9% of total revenues, reflecting ongoing investments in capacity and capability expansions in support of the Company's CDMO services business and product portfolio.

    Q1 2021 REVENUE FORECAST

    For Q1 2021, the Company expects total revenues of $330 million to $370 million.

    FOOTNOTES

    (1) All financial information incorporated within this release is unaudited

    (2) See "Reconciliation of Net Income to Adjusted Net Income and Adjusted EBITDA, Gross Margin and Adjusted Gross Margin and Net Research and Development Expenses" for a definition of terms and reconciliation tables.

    CONFERENCE CALL AND WEBCAST INFORMATION

    Company management will host a conference call at 5:00 pm (Eastern Time) today, February 18, 2021, to discuss these financial results. The conference call can be accessed from the Company's website or through the following:

    Live Teleconference Information:

    Dial in: [US] (855) 766-6521; [International] (262) 912-6157

    Conference ID: 3948196



    Live Webcast Information:

    Visit https://edge.media-server.com/mmc/p/hmesjhe3 for the webcast.
     

    A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."

    ABOUT EMERGENT BIOSOLUTIONS INC.

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

    RECONCILIATION OF NON-GAAP MEASURES

    This press release contains financial measures (Adjusted Net Income, Adjusted EBITDA (Earnings Before Depreciation and Amortization, Interest and Taxes, Gross Margin, Adjusted Gross Margin and Net Research and Development expenses)) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company's definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted net income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges. All adjustments are tax effected utilizing the federal statutory tax rate for the US, except for changes in the fair value of contingent consideration as the vast majority is non-deductible for tax purposes. Adjusted net income margin is defined as adjusted net income divided by total revenues. Adjusted EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and income tax provision (benefit), excluding specified items that can be highly variable and the non-cash impact of certain accounting adjustments. Adjusted EBITDA margin is defined as Adjusted EBITDA divided by total revenues. Gross margin reflects adjusted revenues minus cost of product sales and contract development and manufacturing services (COGS). Adjusted revenues is calculated as total revenues minus contracts and grants revenues. Gross margin percentage is calculated as gross margin divided by adjusted revenues. Adjusted gross margin adjusts COGS for specified items that can be highly variable or difficult to predict, or to reflect the non-cash impacts of charges (Adjusted COGS). Adjusted gross margin is calculated as adjusted revenues minus adjusted COGS. Adjusted gross margin percentage is calculated as adjusted gross margin divided by adjusted revenues. Net research and development expenses reflects research and development expenses adjusted to reflect expenses which are funded (contracts and grants revenue) and non-cash impairment of IPR&D charges. Net research and development margin is calculated as net research and development divided by adjusted revenue. The Company views these non-GAAP financial measures as a means to facilitate management's financial and operational decision- making, including evaluation of the Company's historical operating results and comparison to competitors' operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company's operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure may provide a more complete understanding of factors and trends affecting the Company's business.

    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. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety.

    SAFE HARBOR STATEMENT

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact,  including,  without  limitation,  our  financial guidance and related projections and statements regarding our ability to meet such projections in the anticipated timeframe, if at all; statements regarding continuing to execute on our strategy across all four of our business units; remaining leaders in the market and creating long-term shareholder value; the effectiveness of COVID-HIG at treating   adult patients hospitalized with COVID-19 and its effectiveness as potential post-exposure prophylaxis in individuals at  high risk of exposure to COVID-19, such as front-line health care workers and military personnel; normalized annual  anthrax vaccine revenue levels and continued procurement under the Company's existing contract with BARDA; continued ACAM2000 vaccine deliveries consistent with 2020 deliveries; the results of the appellate decision related to pending patent litigation followed by the entry of at least one competitor for NARCAN® Nasal Spray 4mg/spray; continued performance of CDMO services for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers; pipeline progress and at least one BLA  or EUA submission in 2021; the percentage of capital expenditures as a percentage of total revenues (net of reimbursement), ongoing investments in capacity and capability expansions  in  support  of  the  Company's  CDMO services business and product portfolio; our CDMO backlog  and  opportunity  funnel and any other  statements containing  the  words  "will,"  "believes,"  "expects,"  "anticipates,"  "intends"  "plans,"  "targets,"  "forecasts," "estimates" and similar expressions in conjunction with, among other things, discussions of the Company's outlook, financial performance or financial condition, financial and operation goals, strategic  goals,  growth  strategy,  product sales, government development or procurement contracts or awards, government appropriations, manufacturing capabilities, and the timing of certain regulatory approvals or expenditures are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate.

    Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place  undue reliance on any forward-looking statement. Any forward-looking statements speak only as of the date of this press  release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the impact of global economic conditions and public health crises and epidemics, such as the global pandemic that arose from COVID-19, on the markets, our operations, and employees as well as those of our customers and suppliers; availability of U.S. government funding for procurement for our products and certain product candidates and the future exercise of options under contracts related to such procurement; the negotiation of further commitments or contracts related to the collaboration and deployment of capacity toward future commercial manufacturing under our CDMO contracts; our ability to perform under our contracts with the U.S. government and our CDMO clients, including the timing of and specifications relating to deliveries; the continued exercise of discretion by BARDA to procure additional doses of AV7909 prior to approval by the FDA; our ability to secure licensure of AV7909 from the FDA within the anticipated timeframe, if at all; our ability to secure follow-on procurement contracts for our solutions to public health threats that are under procurement contracts that have expired or will be expiring; our ability to successfully appeal the patent litigation decision related to NARCAN® Nasal Spray 4mg/spray; our ability and the ability of our collaborators to enforce patents related to NARCAN® Nasal Spray against potential generic entrants; our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria; our ability and the ability of our contractors and suppliers to maintain compliance with Current Good Manufacturing Practices and other regulatory obligations; our ability to obtain or maintain FDA approval or authorization for emergency or broader patient use of our COVID-19 treatment candidates and their actual safety and effectiveness; timing of and results of clinical trials; our ability to comply with the operating and financial covenants required by our senior secured credit facilities and the indenture governing our senior unsecured notes due 2028; our ability to obtain and maintain regulatory approvals for our other product candidates and the timing of any such approvals; the procurement of products by U.S. government entities under regulatory exemptions prior to approval by the FDA and corresponding procurement by government entities outside of the United States under regulatory exemptions prior to approval by the corresponding regulatory authorities in the applicable country; the success of our commercialization, marketing and manufacturing capabilities and strategy; and the accuracy of our estimates regarding future revenues, expenses, and capital requirements and needs for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission when evaluating our forward-looking statements.

    Investor Contact

    Robert Burrows

    Vice President, Investor Relations

    (o) 240/631-3280; (m) 240/413-1917

                  Media Contact

    Nina DeLorenzo

    SVP, Global Communications & Public Affairs

       

    Emergent BioSolutions Inc.

    Consolidated Balance Sheets

    (unaudited in millions, except per share data)

     December 31,
     20202019
    ASSETS      
    Current assets:      
    Cash and cash equivalents$621.3 $167.8 
    Restricted cash 0.2  0.2 
    Accounts receivable, net 230.9  270.7 
    Inventories 307.0  222.5 
    Prepaid expenses and other current assets 36.5  25.0 
    Total current assets 1,195.9  686.2 
           
    Property, plant and equipment, net 644.1  542.3 
    Intangible assets, net 663.1  712.9 
    In-process research and development   29.0 
    Goodwill 266.7  266.6 
    Other assets 113.4  90.3 
    Total assets$2,883.2 $2,327.3 
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable 136.1  94.8 
    Accrued expenses46.9  39.5 
    Accrued compensation84.6  62.4 
    Debt, current portion33.8  12.9 
    Other current liabilities83.1  6.7 
    Total current liabilities384.5  216.3 
           
    Contingent consideration, net of current portion 34.2  26.0 
    Debt, net of current portion 841.0  798.4 
    Deferred tax liability 53.2  63.9 
    Contract liabilities, net of current portion 55.5  85.6 
    Other liabilities 67.8  48.6 
    Total liabilities$1,436.2 $1,238.8 



    Stockholders' equity:      
    Preferred stock, $0.001 par value; 15.0 shares authorized, no shares issued and outstanding    
           
    Common stock, $0.001 par value; 200.0 shares authorized, 54.3 and 53.0 shares issued; 53.1 and 51.7 shares outstanding, respectively. 0.1  0.1 
    Treasury stock, at cost, 1.2 common shares (39.6) (39.6)
    Additional paid-in capital 784.9  716.1 
    Accumulated other comprehensive loss, net (25.3) (9.9)
    Retained earnings 726.9  421.8 
    Total stockholders' equity 1,447.0  1,088.5 
    Total liabilities and stockholders' equity$2,883.2 $2,327.3 
           

    Emergent BioSolutions Inc.

    Consolidated Statements of Operations

    (unaudited in millions, except per share data)

     Three Months Ended December 31,
     20202019
    Revenues:      
    Product sales, net$340.9 $310.8 
    Contract development and manufacturing services 199.1  25.5 
    Contracts and grants 43.0  24.1 
    Total revenues 583.0  360.4 
         
    Operating expenses:    
    Cost of product sales and contract development and manufacturing services 168.3  132.8 
    Research and development 59.5  62.8 
    Selling, general and administrative 82.1  72.2 
    Amortization of intangible assets 15.0  14.8 
    Total operating expenses 324.9  282.6 
           
    Income from operations 258.1  77.8 
           
    Other income (expense):      
    Interest expense (8.7) (9.1)
    Other, net 3.4  2.8 
    Total other income (expense), net (5.3) (6.3)
           
    Income before income taxes 252.8  71.5 
    Income taxes 67.4  24.6 
    Net income$185.4 $46.9 
           
    Net Income per common share      
    Basic$3.51 $0.91 
    Diluted$3.44 $0.90 
         
    Shares used in computing income per share    
    Basic53.1 51.7 
    Diluted54.2 52.6 
         

    Emergent BioSolutions Inc.

    Consolidated Statements of Operations

    (unaudited in millions, except per share data)

     Year Ended December 31,
     20202019
    Revenues:      
    Product sales, net$989.8 $903.5 
    Contract development and manufacturing services 450.5  80.0 
    Contracts and grants 115.1  122.5 
    Total revenues 1,555.4  1,106.0 
           
    Operating expenses:      
    Cost of product sales and contract development and manufacturing services 524.0  433.5 
    Research and development 234.5  226.2 
    Selling, general and administrative 303.3  273.5 
    Amortization of intangible assets 59.8  58.7 
    Total operating expenses 1,121.6  991.9 
           
    Income from operations 433.8  114.1 
           
    Other income (expense):      
    Interest expense (31.3) (38.4)
    Other, net 4.7  1.7 
    Total other income (expense), net (26.6) (36.7)
           
    Income before income taxes 407.2  77.4 
    Income taxes 102.1  22.9 
    Net income$305.1 $54.5 
           
    Net Income per common share      
    Basic$5.79 $1.06 
    Diluted$5.67 $1.04 
         
    Shares used in computing income per share    
    Basic52.7 51.5 
    Diluted53.8 52.4 
         

    Emergent BioSolutions Inc.

    Consolidated Statements of Cash Flows

    (unaudited in millions)

     Year Ended December 31,
     20202019
    Cash flows from operating activities:      
    Net income$305.1 $54.5 
    Adjustments to reconcile to net cash provided by operating activities:      
    Stock-based compensation expense 51.0  26.7 
    Depreciation and amortization 114.5  110.7 
    Impairment of intangible asset 29.0  12.0 
    Change in fair value of contingent obligations, net 31.7  24.8 
    Amortization of deferred financing costs 3.5  3.0 
    Deferred income taxes (2.4) (1.1)
    Other

     (5.2) (0.2)
    Changes in operating assets and liabilities, net of business acquisitions:      
    Accounts receivable 49.0  (8.2)
    Inventories (83.2) (16.7)
    Prepaid expenses and other assets (29.2) (39.1)
    Accounts payable 19.8  16.5 
    Accrued expenses and other liabilities 19.4  (15.1)
    Accrued compensation 21.8  4.2 
    Contract liabilities 11.2  16.0 
    Net cash provided by operating activities 536.0  188.0 
    Cash flows from investing activities:      
    Purchases of property, plant and equipment and other (141.0) (86.9)
    Milestone payment from asset acquisition (10.0) (10.0)
    Net cash used in investing activities (151.0) (96.9)
    Cash flows from financing activities:      
    Proceeds from revolving credit facility   130.0 
    Principal payments on revolving credit facility (373.0) (105.0)
    Proceeds from term loan facility    
    Principal payments on term loan facility (14.1) (11.3)
    Proceeds from senior unsecured notes 450.0   
    Debt issuance costs (8.4)  
    Proceeds from share-based compensation activity 31.6  8.2 
    Taxes paid for share-based compensation activity (13.8) (7.4)
    Contingent consideration payments (2.8) (50.4)
    Net cash (used in) provided by financing activities 69.5  (35.9)
    Effect of exchange rate changes on cash and cash equivalents (1.0) 0.4 
    Net change in cash and cash equivalents and restricted cash 453.5  55.6 
    Cash and cash equivalents and restricted cash at beginning of year 168.0  112.4 
    Cash and cash equivalents and restricted cash at end of year$621.5 $168.0 
           

    Reconciliation of Net Income to Adjusted Net Income

     Three Months Ended December 31,
    (in millions, except per share value) 2020  2019 Source
    Net Income$185.4 $46.9  
    Adjustments:       
    + Non-cash amortization charges 16.2  15.6 Intangible Asset Amortization, Other Income
    + Changes in fair value of contingent consideration 0.4  12.4 COGS
    + Exit and disposal costs 0.1   COGS, SG&A, Other Income
    + Acquisition-related costs (transaction & integration) 0.1  2.0 SG&A
    + Impairment of IPR&D intangible asset   12.0 R&D
    Tax effect (3.4) (6.2) 
    Total Adjustments: 13.4  35.8  
    Adjusted Net Income$198.8 $82.7  
    Adjusted Net Income Per Diluted Share$3.67 $1.57  
            



     Year Ended December 31,
    (in millions, except per share value) 2020  2019 Source
    Net Income$305.1 $54.5  
    Adjustments:
    + Non-cash amortization charges 63.4  61.7 Intangible Asset Amortization, Other Income
    + Change in fair value of contingent consideration 31.7  24.8 COGS
    + Impairment of IPR&D 29.0  12.0 R&D
    + Exit and disposal costs 17.2   COGS, SG&A, Other Income
    + Acquisition-related costs (transaction & integration) 0.6  12.6 SG&A
    + Impact of purchase accounting on inventory step-up   6.1 COGS
    Tax effect (23.1) (19.4) 
    Total Adjustments: 118.8  97.8  
    Adjusted Net Income$423.9 $152.3  
    Adjusted Net Income Per Diluted Share$7.88 $2.91  
            



     Full Year Forecast

     
    (in millions)2021FSource
    Net Income$420.0 - $470.0  
    Adjustments:
    + Non-cash amortization charges64.0 Intangible Asset Amortization, Other Income
    + Changes in fair value of contingent consideration3.0 COGS
    + Acquisition-related costs (transaction & integration)2.0 SG&A
    Tax effect(14.0) 
    Total Adjustments:55.0  
    Adjusted Net Income$475.0 - $525.0  
        

    Reconciliation of Net Income to EBITDA and Adjusted EBITDA

     Three Months Ended December 31,
    (in millions) 2020 2019
    Net Income$185.4$46.9
    Adjustments: 
    + Depreciation & amortization 28.9 27.9
    + Income Taxes 67.4 24.6
    + Total interest expense, net* 8.6 8.5
    + Change in fair value of contingent consideration 0.4 12.4
    + Exit and disposal costs* 0.1 
    + Acquisition-related costs (transaction & integration) 0.1 2.0
    + Impairment of IPR&D intangible asset  12.0
    Total Adjustments 105.5 87.4
    Adjusted EBITDA$290.9$134.3
    * Includes interest income of $0.1 million in 2020 and $0.7 million in 2019
     



     Year Ended December 31,
    (in millions)20202019
    Net Income$305.1$54.5
    Adjustments:  
    + Depreciation & amortization 114.5 110.7
    + Total interest expense, net* 30.2 36.1
    + Income tax expense 102.1 22.9
    + Change in fair value of contingent consideration 31.7 24.8
    + Impairment of IPR&D intangible asset 29.0 12.0
    + Exit and disposal costs 17.2 
    + Acquisition-related costs (transaction & integration) 0.6 12.6
    + Impact of purchase accounting on inventory step-up  6.1
    Total Adjustments 325.3 225.2
    Adjusted EBITDA$630.4$279.7
    * Includes interest income of $1.1 million in 2020 and $2.4 million in 2019
     







    (in millions)
    Full Year Forecast
    2021F
    Net Income$420.0 - $470.0
    Adjustments:
    + Depreciation & amortization133.0
    + Income taxes161.0 - 171.0
    + Total interest expense31.0
    + Acquisition-related costs (transaction & integration)2.0
    + Change in fair value of contingent consideration3.0
    Total Adjustments330.0 - 340.0
    Adjusted EBITDA$750.0 - $810.0
      

    Reconciliation of Gross Margin and Adjusted Gross Margin

    (in millions)Three Months Ended December 31,Twelve Months Ended December 31,
     2020  2019  2020  2019 
    Total revenues$583.0 $360.4 $1,555.4 $1,106.0 
    Less: Contract and grants revenues (43.0) (24.1) (115.1) (122.5)
    Adjusted revenues$540.0 $336.3 $1440.3 $983.5 
     
    Cost of product sales and contract development and manufacturing services ("COGS")$168.3 $132.8 $524.0 $433.5 
    - Changes in fair value of contingent consideration (0.4) (12.4) (31.7) (24.8)
    - Inventory reserves related to Travel Health vaccines 1.5    (12.6)  
    Adjusted COGS$169.4 $120.4 $479.7 $408.7 
     
    Gross margin (adjusted revenues minus COGS)$371.7 $203.5 $916.3 $550.0 
    Gross margin % (gross margin divided by adjusted revenues) 69% 61% 64% 56%
     
    Adjusted gross margin (adjusted revenues minus adjusted COGS)$370.6 $215.9 $960.6 $574.8 
    Adjusted gross margin % (adjusted gross margin divided by adjusted revenues) 69% 64% 67% 58%
                 

    Reconciliation of Net Research and Development Expenses

    (in millions)Three Months Ended December 31,
     2020  2019 % Change
    Research and Development Expenses$59.5 $62.8 (5)%
    Adjustments:
    Less: Contracts and Grants Revenue 43.0  24.1 78%
    Less: Impairment of IPR&D   12.0 *
    Net Research and Development Expenses 16.5  26.7 (38)%
    Adjusted Revenue (Total Revenue less Contracts and Grants Revenue)$540.0 $336.3 61%
    Net R&D as % of Adjusted Revenue (Net R&D Margin) 3% 8%(63)%
             



    (in millions)Year Ended December 31,
     2020  2019 % Change
    Research and Development Expenses$234.5 $226.2 4%
    Adjustments:
    Less: Contracts and Grants Revenue 115.1  122.5 (6)%
    Less: Impairment of IPR&D 29.0  12.0 *
    Net Research and Development Expenses 90.4  91.7 (1)%
    Adjusted Revenue (Total Revenue less Contracts and Grants Revenue)$1,440.3 $983.5 46%
    Net R&D as % of Adjusted Revenue (Net R&D Margin) 6% 9%(33)%
             


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  1. GAITHERSBURG, Md., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) will host a conference call on Thursday, February 18, 2021 at 5:00 pm eastern time to discuss the financial results for the fourth quarter and full year 2020, recent business developments, financial outlook for full year 2021, and revenue guidance for the first quarter of 2021.

    This conference call can be accessed live by telephone or by webcast:

    Teleconference Information:
    Dial in number – toll-free: (855) 766-6521
    Dial in number – toll: (262) 912-6157
    Conference ID: 3948196
     
    Webcast Information:
    Visit https://edge.media-server.com/mmc/p/hmesjhe3 for the live webcast.

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

    About Emergent BioSolutions

    GAITHERSBURG, Md., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) will host a conference call on Thursday, February 18, 2021 at 5:00 pm eastern time to discuss the financial results for the fourth quarter and full year 2020, recent business developments, financial outlook for full year 2021, and revenue guidance for the first quarter of 2021.

    This conference call can be accessed live by telephone or by webcast:

    Teleconference Information:

    Dial in number – toll-free: (855) 766-6521

    Dial in number – toll: (262) 912-6157

    Conference ID: 3948196
     
    Webcast Information:
    Visit https://edge.media-server.com/mmc/p/hmesjhe3 for the live webcast.

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

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit our website and follow us on LinkedIn, Twitter, and Instagram.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

    Media Contact:

    Nina DeLorenzo

    SVP, Global Communications & Public Affairs

     



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  2. Emergent BioSolutions Inc. (NYSE:EBS) (Emergent) and Humanigen, Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have entered into a contract development and manufacturing (CDMO) services agreement to accelerate the drug product manufacturing of lenzilumab™, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called "cytokine storm." Emergent will provide access to manufacturing capacity reserved for and provided by the U.S. government under Humanigen's Cooperative Research and Development Agreement (CRADA) with the Department of Defense's (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND…

    Emergent BioSolutions Inc. (NYSE:EBS) (Emergent) and Humanigen, Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have entered into a contract development and manufacturing (CDMO) services agreement to accelerate the drug product manufacturing of lenzilumab™, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called "cytokine storm." Emergent will provide access to manufacturing capacity reserved for and provided by the U.S. government under Humanigen's Cooperative Research and Development Agreement (CRADA) with the Department of Defense's (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization (EUA) in the first quarter of 2021.

    Under the terms of the agreement, Emergent will provide its integrated CDMO services for the manufacturing of drug product batches to support Humanigen's efforts to increase supply of lenzilumab in anticipation of a potential EUA beginning in the first quarter of 2021, including utilization of a new state-of-the-art flex fill line at Emergent's Baltimore, MD (Camden) drug product manufacturing facility. This newly expanded facility was built to provide increased capacity and flexibility to support companies in need of clinical and commercial manufacturing capabilities. The parties intend to negotiate a commercial manufacturing services agreement that could include future fill batches for a biologics license application (BLA).

    "As we continue to advance lenzilumab for patients hospitalized with COVID-19, we are executing on plans to ensure that we have the necessary support for the next phase of our growth. Partnering with leading CDMOs like Emergent BioSolutions to help us build out our manufacturing capacity is a cornerstone to that strategy," said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. "The impact of BARDA's support through our CRADA and its public-private CDMO partnership with Emergent is vital to our progress and bringing innovative solutions for patients with COVID-19."

    For Emergent, this agreement follows and is in addition to the landmark public-private CDMO partnership between Emergent and BARDA, announced in June 2020, to pave the way for high-priority innovators leveraging reserved capacity at their Drug Substance and Drug Product facilities.

    "Drug product manufacturing is a hallmark capability of our CDMO services, and we stand ready to harness our expertise to advance lenzilumab, Humanigen's COVID-19 therapeutic candidate," said Syed T. Husain, senior vice president and CDMO business unit head at Emergent BioSolutions. "Every second counts in the fight against COVID-19, and we are proud that Humanigen trusts us to rapidly deploy our clinical-to-commercial manufacturing operations to fulfill the urgent need for COVID-19 therapeutic options."

    This agreement marks Emergent's seventh CDMO collaboration with government and industry partners working to deliver COVID-19 vaccine and therapeutic solutions.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through Emergent's specialty products and contract development and manufacturing services, Emergent is dedicated to providing solutions that address public health threats. Through social responsibility, Emergent aims to build healthier and safer communities. Emergent aspires to deliver peace of mind to its patients and customers so they can focus on what's most important in their lives. In working together, Emergent envisions protecting or enhancing 1 billion lives by 2030. For additional information, visit Emergent's website and follow Emergent on LinkedIn, Twitter and Instagram.

    About Humanigen, Inc.

    Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. Humanigen's immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. Humanigen is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.

    Emergent BioSolutions Safe Harbor Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding Emergent's ability to advance potential solutions to combat coronavirus disease as well as the anticipated production of the lenzilumabPhase 3 COVID-19 experimental therapeutic candidate at expected levels in the expected timeframe, as well as the potential negotiation of a future commercial manufacturing services agreement that could include fill batches for a BLA, are forward-looking statements. These forward-looking statements are based on current intentions, beliefs and expectations regarding future events. Emergent cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Emergent does not undertake to update any forward-looking statement to reflect new information, events or circumstances.

    There are a number of important factors that could cause Emergent's actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development program; the timing of and ability to obtain and maintain regulatory approvals or authorization for emergency or broader patient use for the product candidate; and Emergent's commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Emergent's periodic reports filed with the SEC, when evaluating Emergent's forward-looking statements.

    Humanigen Forward-Looking Statements

    This press release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although Humanigen management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the use of lenzilumab to treat patients hospitalized with COVID-19, Humanigen's expectations regarding the timeline to file for and obtain EUA, as well as a potential BLA filing, statements regarding Humanigen's ability to attain necessary manufacturing support from CDMOs, the potential for an expanded manufacturing services relationship with Emergent, and statements regarding Humanigen's beliefs relating to any of the other technologies in Humanigen's current pipeline. These forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in Humanigen's lack of profitability and need for additional capital to grow Humanigen's business; Humanigen's dependence on partners to further the development of Humanigen's product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals or authorization for emergency or broader patient use for the product candidate and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Humanigen's periodic and other filings with the Securities and Exchange Commission.

    All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. Humanigen undertakes no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

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    • Expects continued strong financial and operating momentum in 2021, forecasting total revenues of $2 billion at the midpoint and Adjusted EBITDA of $780 million at the midpoint, both increases year-over-year
    • Reports preliminary 2020 total revenues of $1.55 billion at the midpoint and Adjusted EBITDA of $635 million at the midpoint, both at or above prior guidance given in November 2020

    GAITHERSBURG, Md., Jan. 10, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced its financial forecast for 2021 and selected preliminary unaudited financial results for 2020.

    "In a year full of unprecedented challenges due to the pandemic, the Emergent team's unwavering commitment produced incredible results," said Robert G. Kramer…

    • Expects continued strong financial and operating momentum in 2021, forecasting total revenues of $2 billion at the midpoint and Adjusted EBITDA of $780 million at the midpoint, both increases year-over-year
    • Reports preliminary 2020 total revenues of $1.55 billion at the midpoint and Adjusted EBITDA of $635 million at the midpoint, both at or above prior guidance given in November 2020

    GAITHERSBURG, Md., Jan. 10, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced its financial forecast for 2021 and selected preliminary unaudited financial results for 2020.

    "In a year full of unprecedented challenges due to the pandemic, the Emergent team's unwavering commitment produced incredible results," said Robert G. Kramer, president and chief executive officer. "Operationally, we rapidly responded to our customers' needs, and financially, we delivered record revenue and earnings. We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. We look forward to continuing to execute on our strategy and building on the momentum created in 2020 across all four of our business units."

    "Our 2020 financial performance clearly demonstrates the resilience and durability of our diversified portfolio of products and services," said Richard S. Lindahl, executive vice president and chief financial officer. "We enter 2021 with positive momentum and are poised to deliver robust double-digit gains in total revenues and non-GAAP earnings for the fifth consecutive year. One year into our five-year strategy, we are increasingly confident in the growth prospects for the business."

    PRELIMINARY 2020 FINANCIAL RESULTS (Unaudited)

    The Company is providing the following preliminary, unaudited financial results for full year 2020.

    (in millions)PRELIMINARY RESULTS

    (As of 1/10/2021)
    PRIOR 2020 GUIDANCE

    (As of 11/5/2020)
    Total Revenues$1,545 - $1,555$1,520 - $1,580
    Net Income$295 - $310$255 - $285
    Adjusted EBITDA (1)$625 - $645$575 - $615
    Adjusted Net Income (1)$415 - $430$375 - $405

    Revenue Metrics

    Total revenues for 2020 are expected to be in the range of $1,545 and $1,555 million, an increase at the midpoint of $444 million or 40% as compared to 2019. This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales.

    Profitability Metrics

    The Company anticipates Adjusted EBITDA of $625 to $645 million, which at the midpoint represents an increase of $355 million or 127% as compared to 2019. The Company anticipates Adjusted Net Income of $415 to $430 million, which at the midpoint represents an increase of $270 million or 177% as compared to 2019. This growth primarily reflects the forecasted increase in total revenues discussed above. (See "Reconciliation of Non-GAAP Measures" for a definition of the terms and reconciliation tables.)

    Note:

    The preliminary 2020 financial results are unaudited, subject to revision, and anticipated to be finalized by late February 2021. The Company's final audited financial results could differ materially from these selected preliminary results.

    2021 FINANCIAL FORECAST

    The Company is providing the following forecast of selected financial metrics for full year 2021.





    (in millions)
    FULL YEAR 2021

    (As of 1/10/2021)
    Total Revenues$1,950 - $2,050
    Adjusted EBITDA (1)$750 - $810
    Adjusted Net Income (1)$475 -- $525
      
    Product/Service Level Revenue 
     •  Anthrax Vaccines$280 -- $310
     •  ACAM2000$185 -- $205
     •  NARCAN® Nasal Spray$305 -- $325
     •  CDMO Services$925 -- $965
     •  Other Products and Contracts and Grants$220 -- $240

    Total Revenues

    The 2021 forecast for total revenues reflects continued growth in aggregate product revenues and significant growth in services revenue from the CDMO business.

    Adjusted EBITDA and Adjusted Net Income (1)

    The 2021 forecast reflects an anticipated mix of product and services gross margin, continued investment in research and development, and scale efficiencies in selling, general & administration expenses.

    2021 Product/Service Level Revenues – Select Assumptions

    • Anthrax vaccine revenues are expected to be at a more normalized annual level and continue to primarily reflect procurement of AV7909 (Anthrax Vaccine Adsorbed, adjuvanted) under the Company's existing contract with the Biomedical Advanced Research and Development Authority (BARDA).
    • ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) vaccine deliveries are expected to continue under the terms of the Company's existing contract with the U.S. Department of Health and Human Services (HHS) at unit volume levels consistent with 2020 deliveries.
    • Narcan® (naloxone HCl) Nasal Spray revenues assume no generic competition prior to the resolution of the Company's appeal of the patent litigation regarding the 4mg form of this intranasal spray product.
    • CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers.

    Other 2021 Assumptions

    • Gross margin is expected to be approximately 65% on a GAAP basis, influenced by the mix of product and services revenues.
    • A follow-on procurement contract with HHS is expected for the delivery of raxibacumab, the Company's Food and Drug Administration-approved anthrax monoclonal antibody therapeutic, to the Strategic National Stockpile (SNS).
    • Pipeline progress is expected across the vaccines, therapeutics, and devices portfolios, anticipating at least one Phase 3 launch and one Biologics License Application (BLA)/Emergency Use Authorization (EUA) filing.
    • Capital expenditures, net of reimbursement, are expected to be in a range of 8% to 9% of total revenues, reflecting ongoing investments in capacity and capability expansions related to the CDMO business and the Company's product portfolio.

    FOOTNOTES

    (1)   See "Reconciliation of Non-GAAP Measures" for a definition of terms and applicable reconciliation tables.

    PRESENTATION WEBCAST

    The Company will provide an update on the current business and discuss preliminary 2020 financial results, the forecast and corporate goals for 2021, and long-term goals during its presentation at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021 at 8:20 AM Eastern time.

    A live webcast of the presentation can be accessed through Emergent's website. An on-demand replay of the webcast can also be accessed in the investors section after the presentation has concluded.

    RECONCILIATION OF NON-GAAP MEASURES (unaudited)

    This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company's definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted net income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges. All adjustments are tax effected utilizing the federal statutory tax rate for the US, except for changes in the fair value of contingent consideration as the vast majority is non-deductible for tax purposes. Adjusted EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and income taxes, excluding specified items that can be highly variable and the non-cash impact of certain accounting adjustments. The Company views these non-GAAP financial measures as a means to facilitate management's financial and operational decision-making, including evaluation of the Company's historical operating results and comparison to competitors' operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company's operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure may provide a more complete understanding of factors and trends affecting the Company's business.

    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. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety.

    This press release references increases in Revenues, Adjusted EBITDA, and Adjusted Net Income from the Company's full year 2019 performance to the mid-point of the estimated full year 2020 performance. The Company believes these metrics are an important part of assessing the improvement in performance on a year over year basis. These increases are expressed in dollars as well as percentages. A reconciliation of the calculation of these increases is included below.

    Reconciliation of Net Income to Adjusted Net Income (Unaudited)

    (in millions, except per share value)

    Twelve Months Ended December 31,
    2021

    (Forecast)
    2020

    (Estimated)
    2019

    (Actual)
    Source
    Net income$420.0 - $470.0$295.0 - $310.0$54.5 
    Adjustments:
    + Non-cash amortization charges64.064.061.7Intangible Asset Amortization, Other Income
    + Changes in fair value of contingent consideration3.032.024.8COGS
    + Impairment of IPR&D intangible asset29.012.0R&D
    + Exit and disposal costs17.0COGS, SG&A, Other Income
    + Acquisition-related costs (transaction & integration)2.01.012.6SG&A
    + Impact of purchase accounting on inventory step-up6.1COGS
    Tax effect(14.0)(23.0)(19.4) 
    Total adjustments:$55.0$120.0$97.8 
    Adjusted net income$475.0 - $525.0$415.0 - $430.0$152.3 

    Reconciliation of Net Income to Adjusted EBITDA (Unaudited)

    (in millions)

    Twelve Months Ended December 31,
    2021

    (Forecast)
    2020

    (Estimated)
    2019

    (Actual)
    Source
    Net income$420.0 - $470.0$295.0 - $310.0$54.5 
    Adjustments:
    + Depreciation & amortization133.0115.0110.7COGS, SG&A, R&D
    + Income taxes161.0 - 171.0106.0 - 111.022.9Income Taxes
    + Total interest expense, net31.030.036.1Other Expense
    + Changes in fair value of contingent consideration3.032.024.8COGS
    + Impairment of IPR&D intangible asset29.012.0R&D
    + Exit and disposal costs17.0COGS, SG&A, Other Income
    + Acquisition-related costs (transaction & integration)2.01.012.6SG&A
    + Impact of purchase accounting on inventory step-up6.1COGS
    Total adjustments$330.0 - $340.0$330.0 - $335.0$225.2 
    Adjusted EBITDA$750.0 - $810.0$625.0 - $645.0$279.7 

    Reconciliation of the 2020 Estimated Midpoint of Revenues, Adjusted EBITDA and Adjusted Net Income and the Dollar and Percentage Increases as compared to 2019 Actual (Unaudited)

    (in millions, except percentage increase at midpoint of range) 
    Twelve Months Ended December 31,RevenuesAdjusted EBITDAAdjusted Net Income
    2020 (Estimated) Range$1,545.0 - $1,555.0$625.0 - $645.0$415.0 - $430.0
    2020 (Estimated) Midpoint of Range$1,550.0$635.0$422.5
    2019 (Actual)$1,106.0$279.7$152.3
    Increase at Midpoint of Range ($)$444.0$355.3$270.2
    Percentage Increase at Midpoint of Range40%127%177%

    ABOUT EMERGENT BIOSOLUTIONS

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit our website and follow us on LinkedIn, Twitter, and Instagram.

    SAFE HARBOR STATEMENT

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, our financial guidance and related projections and statements regarding our ability to meet such projections in the anticipated timeframe, if at all; statements regarding continuing to execute on our strategy; entering into 2021 building on the momentum created in 2020 across all four of our business units; strong financial and operating momentum in 2021; the resilience and durability of our portfolio; being poised to deliver robust double-digit gains in total revenues and non-GAAP earnings; gross margin and our level of capital expenditures; continued procurement of AV7909 and ACAM2000 vaccine deliveries; no generic competition for Narcan® Nasal Spray prior to the resolution of the Company's appeal of the patent litigation regarding the 4mg form of this intranasal spray product; entering into a follow-on procurement contract with the U.S. Department of Health and Human Services for the delivery of raxibacumab; overall growth prospects for the business, including continued CDMO growth and further pipeline progress in other business units, including at least one Phase 3 launch, one Biologics License Application/Emergency Use Authorization filing; and any other statements containing the words "will," "believes," "expects," "anticipates," "intends," "plans," "targets," "forecasts," "estimates" and similar expressions in conjunction with, among other things, discussions of the Company's outlook, financial performance or financial condition, financial and operation goals, strategic goals, growth strategy, product sales, government development or procurement contracts or awards, government appropriations, manufacturing capabilities, and the timing of certain regulatory approvals or expenditures are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate.

    Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statements speak only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the impact of global economic conditions and public health crises and epidemics, such as the global pandemic that arose from COVID-19, on the markets, our operations, and employees as well as those of our customers and suppliers; availability of U.S. government funding for procurement for our products and certain product candidates and the future exercise of options under contracts related to such procurement; the negotiation of further commitments or contracts related to the collaboration and deployment of capacity toward future commercial manufacturing under our CDMO contracts; our ability to perform under our contracts with the U.S. government and our CDMO clients, including the timing of and specifications relating to deliveries; the continued exercise of discretion by BARDA to procure additional doses of AV7909 prior to approval by the FDA; our ability to secure licensure of AV7909 from the FDA within the anticipated timeframe, if at all; our ability to secure follow-on procurement contracts for our solutions to public health threats that are under procurement contracts that have expired or will be expiring; our ability to successfully appeal the patent litigation decision related to NARCAN® Nasal Spray 4mg/spray; our ability and the ability of our collaborators to enforce patents related to NARCAN® Nasal Spray against potential generic entrants; our ability and the ability of our contractors and suppliers to maintain compliance with Current Good Manufacturing Practices and other regulatory obligations; our ability to obtain or maintain FDA approval or authorization for emergency or broader patient use of our COVID-19 treatment candidates and their actual safety and effectiveness; timing of and results of clinical trials; our ability to comply with the operating and financial covenants required by our senior secured credit facilities and the indenture governing our senior unsecured notes due 2028; our ability to obtain and maintain regulatory approvals for our other product candidates and the timing of any such approvals; the success of our commercialization, marketing and manufacturing capabilities and strategy; and the accuracy of our estimates regarding future revenues, expenses, and capital requirements and needs for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission when evaluating our forward-looking statements.

    Investor Contact

    Robert Burrows

    Vice President, Investor Relations

    (o) 240/631-3280; (m) 240/413-1917

    Media Contact

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    (o) 240/631-3392



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  3. GAITHERSBURG, Md., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that members of the company's executive management team will participate in the following investor conferences in the first quarter of 2021:

    • 39th Annual J.P. Morgan Healthcare Conference
      January 11 to 14, 2021
      Company presentation scheduled on January 11 at 8:20am EST

    • J.P. Morgan 2021 Global High Yield & Leveraged Finance Conference
      March 1 to 3, 2021
      Presentation date and time will be updated on the Emergent website as the information becomes available.

    • Cowen 41st Annual Health Care Conference
      March 1 to 4, 2021
      Presentation date and time will be updated on the Emergent website as the information becomes available.

    For conferences where a presentation…

    GAITHERSBURG, Md., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that members of the company's executive management team will participate in the following investor conferences in the first quarter of 2021:

    • 39th Annual J.P. Morgan Healthcare Conference

      January 11 to 14, 2021

      Company presentation scheduled on January 11 at 8:20am EST



    • J.P. Morgan 2021 Global High Yield & Leveraged Finance Conference

      March 1 to 3, 2021

      Presentation date and time will be updated on the Emergent website as the information becomes available.



    • Cowen 41st Annual Health Care Conference

      March 1 to 4, 2021

      Presentation date and time will be updated on the Emergent website as the information becomes available.

    For conferences where a presentation is planned, the company's webcast presentation may include a discussion of the company's recent business developments as well as its financial results and guidance. The webcasts will be available both live, if possible, and by replay, and will be accessible from the Emergent website.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit our website and follow us on LinkedIn, Twitter, and Instagram.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

      

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392



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  4. GAITHERSBURG, Md. and NEW YORK, Dec. 29, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE:EBS) and Mount Sinai Health System today announced initiation of the clinical program to evaluate Emergent's COVID-19 Human Hyperimmune Globulin (COVID-HIG) product candidate in the first of two Phase 1 studies to support its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as front-line health care workers and military personnel.

    The first study will evaluate safety and pharmacokinetics of three dose levels administered as a single or repeat IV dose in healthy adults. The second study, once initiated, will evaluate safety, pharmacokinetics, and pharmacodynamics…

    GAITHERSBURG, Md. and NEW YORK, Dec. 29, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE:EBS) and Mount Sinai Health System today announced initiation of the clinical program to evaluate Emergent's COVID-19 Human Hyperimmune Globulin (COVID-HIG) product candidate in the first of two Phase 1 studies to support its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as front-line health care workers and military personnel.

    The first study will evaluate safety and pharmacokinetics of three dose levels administered as a single or repeat IV dose in healthy adults. The second study, once initiated, will evaluate safety, pharmacokinetics, and pharmacodynamics of two dose levels administered as a single IV dose to adults with SARS-CoV-2 infection, whether asymptomatic or with mild COVID-19.

    "Emergent is pleased to partner with Mount Sinai, a leader in clinical research to combat COVID-19, and expand the clinical evaluation of COVID-HIG," said Dr. Laura Saward, SVP and Therapeutics Business Unit Head at Emergent BioSolutions. "This innovative public-private partnership represented by government, industry, and healthcare providers has the potential to make a significant impact benefiting our front-line health care workers and others who protect us."

    "Mount Sinai is thrilled to be initiating research into potentially important therapeutics against COVID-19," said Judith A. Aberg, MD, Chief of the Division of Infectious Disease at Mount Sinai Health System. "Our team has developed a great scientific partnership with Emergent and looks forward to performing this important research."

    The existing plasma collection capabilities at Mount Sinai established through its collaboration with Emergent and ImmunoTek Bio Centers has enabled ongoing plasma collection from recovered donors to support the development and manufacture of COVID-HIG for evaluation in clinical trials. The clinical research program, including a planned Phase 2 study, is designed to assess whether prophylaxis with COVID-HIG could help protect individuals following high-risk exposure to SARS-CoV-2.

    The U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) has provided $34.6 million in funding in support of this program.

    "The DOD looks forward to reviewing the results of this important clinical trial and is pleased to support this initiative, which should enhance the nation's rapid response to COVID-19," said Douglas Bryce, the DOD's Joint Program Executive Officer for CBRND. "Working together through public-private partnerships harnesses expertise from government, industry, and academia, increasing our chances of developing safe and effective medical countermeasures for this, and other biological threats."

    Advancing COVID-HIG With U.S. Government Support

    In addition to receiving DOD funding to advance a post-exposure prophylaxis indication for COVID-HIG, Emergent was awarded $14.5 million in April 2020 by the U.S. Department of Health and Human Services (HHS) to develop COVID-HIG as a potential treatment for COVID-19. Emergent's proprietary COVID-HIG product candidate is also being evaluated in a Phase 3 clinical study initiated in October 2020 by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as a potential treatment in hospitalized patients. Mount Sinai serves as a study site.

    About Hyperimmune Globulin

    Hyperimmune globulin, also referred to as polyclonal antibodies, is a concentrated antibody product derived from the antibody-rich plasma of people who were previously infected with and recovered from an illness. In order to produce plasma-derived products, plasma is collected from a pool of human donors and then manufactured, or fractionated, into specialized therapeutic products. COVID-HIG is hyperimmune globulin manufactured from plasma of individuals with elevated levels of antibodies to SARS-CoV-2. COVID-HIG is not approved by the U.S. Food and Drug Administration and its safety and effectiveness have not been established.

    About the Mount Sinai Health System

    The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

    For more information, visit https://www.mountsinai.org or find Mount Sinai on FacebookTwitter and YouTube.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For additional information, visit our website and follow us on LinkedIn, Twitter and Instagram.

    Emergent BioSolutions Safe Harbor Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding whether prophylaxis with COVID-HIG could protect individuals following high-risk exposure to SARS-CoV-2 and significantly benefit front-line healthcare workers and military personnel and the use of COVID-HIG as a potential safe and effective treatment in hospitalized patients are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

    There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the success of the collaboration and planned development programs; the availability of antibody-rich plasma; the results of clinical trials; the timing of and our ability to obtain and maintain FDA approval or authorization for emergency or broader patient use of COVID-HIG; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

    Contacts:

    Emergent BioSolutions

    Media:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392



    Investor:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

    Mount Sinai Health System

    Elizabeth Dowling

    Director, Media Relations

    347-541-0212





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    • Reports strong third quarter and record year to date performance
    • Updates full year guidance — refines revenue ranges and raises profitability ranges

    GAITHERSBURG, Md., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today reported financial results for the three and nine months ended September 30, 2020 and updated its full year 2020 guidance.

    "Over the last 22 years, Emergent has built a solid business founded on demonstrable strengths in partnering, manufacturing, and integrating value-added M&A," said Robert G. Kramer, president and chief executive officer of Emergent BioSolutions. "The strength of our core business and the accelerated growth of our contract development and manufacturing unit validate our strategy…

    • Reports strong third quarter and record year to date performance
    • Updates full year guidance — refines revenue ranges and raises profitability ranges

    GAITHERSBURG, Md., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today reported financial results for the three and nine months ended September 30, 2020 and updated its full year 2020 guidance.

    "Over the last 22 years, Emergent has built a solid business founded on demonstrable strengths in partnering, manufacturing, and integrating value-added M&A," said Robert G. Kramer, president and chief executive officer of Emergent BioSolutions. "The strength of our core business and the accelerated growth of our contract development and manufacturing unit validate our strategy to pursue leadership positions across the public health threat market. Our diverse product and service portfolio gives us continued confidence in executing our strategy, delivering on our commitments to our partners and customers, and creating value for our shareholders."

    FINANCIAL HIGHLIGHTS (unaudited)

    (in millions)Q3 2020Q3 2019$ Change% Change
    Total Revenues$385.2$311.8$73.424%
    Net Income$39.5$43.2($3.7)(9)%
    Adjusted Net Income (1)$119.0$64.8$54.284%
    Adjusted EBITDA (1)$168.1$106.4$61.758%
         
    (in millions)YTD 2020YTD 2019$ Change% Change
    Total Revenues$972.4$745.7$226.730%
    Net Income$119.7$7.6$112.1*
    Adjusted Net Income (1)$225.1$69.6$155.5*
    Adjusted EBITDA (1)$339.5$145.4$194.1*
         
    * % change is greater than 100%

    SELECT Q3 2020 BUSINESS ACCOMPLISHMENTS

    • Completed an offering of $450 million in aggregate principal amount 3.875% Senior Unsecured Notes due in 2028. The Company utilized the proceeds from the offering to repay $353 million outstanding under its revolving credit facility with the remainder to be utilized for general corporate purposes.

       
    • Announced the initiation of a Phase 3 clinical trial sponsored by the National Institutes of Health to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including the Company's COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19.

       
    • Announced U.S. Food and Drug Administration (FDA) approval of the shelf life extension of NARCAN® (naloxone HCl) Nasal Spray from 24 months to 36 months.

       
    • Secured approximately $60 million in new business and existing project extensions across development services, drug substance manufacturing, and drug product manufacturing towards the Company's contract development and manufacturing (CDMO) portfolio.

    2020 FINANCIAL PERFORMANCE (unaudited)

    (I) Quarter Ended September 30, 2020 (Q3)

    Revenues

    Total Revenues

    For Q3 2020, total revenues were $385.2 million, an increase of $73.4 million as compared to 2019. Total revenues reflect an increase in contract development and manufacturing services revenues partially offset by a decrease in product sales and contracts and grants revenues.

    Product Sales

    For Q3 2020, product sales were $202.2 million, a decrease of $54.0 million or 21% as compared to 2019. Other product sales increased due to increased sales of BAT®[Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)] and VIGIV [Vaccinia Immune Globulin Intravenous (Human)] offset by a decline in sales of travel health vaccines.





    (in millions)
    Three Months Ended September 30,
    20202019% Change
    Product Sales
    NARCAN® Nasal Spray$88.8$75.018%
    Anthrax vaccines$73.9$40.383%
    ACAM2000$1.0$112.1(99)%
    Other$38.5$28.834%
    Total Product Sales$202.2$256.2(21)%

    Contract Development and Manufacturing (CDMO) Services

    For Q3 2020, revenue from the Company's contract development and manufacturing operations was $157.1 million, an increase of $137.1 million as compared to 2019. The increase is largely due to the contribution of arrangements across development, drug substance manufacturing, and drug product manufacturing services with industry and government customers.

    Contracts and Grants

    For Q3 2020, revenue from the Company's development-based contracts and grants was $25.9 million, a decrease of $9.7 million as compared to 2019. The decrease primarily reflects the completion of development activities associated with the AV7909 product candidate in 2019, partially offset by recent new development awards related to the Company's COVID-19 product candidates.

    Operating Expenses

    Cost of Product Sales and Contract Development and Manufacturing (CDMO) Services

    For Q3 2020, cost of product sales and contract development and manufacturing services was $149.0 million, an increase of $41.0 million or 38% as compared to 2019. The increase is primarily due to a charge of $29.9 million associated with contingent consideration liabilities due to the increased expectation that the Company will meet its final sales milestone for NARCAN® Nasal Spray, a charge of $13.8 million related to a write-down of inventory balances due to the expected expiration of a portion of the Company's travel health vaccines, and an increase in volume in CDMO services offset by a decline in volume of product sales.

    Research and Development (Gross and Net)

    For Q3 2020, gross R&D expenses were $84.4 million, an increase of $31.0 million or 58% as compared to 2019. The increase primarily reflects the impairment of the Company's in-process research and development (IPR&D) intangible asset of $29.0 million. Excluding this item, research and development expenses were consistent reflecting an increase in costs associated with the Company's COVID-19 therapeutic product candidates offset by a decrease in costs due to the completion of development activities associated with the Company's AV7909 product candidate.

    For Q3 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue and the impact of the IPR&D intangible asset impairment, was $29.5 million, an increase of $11.7 million or 66% as compared to 2019. The increase is attributable to an increase in costs associated with the Company's COVID-19 product candidates. The Q3 2020 and Q3 2019 net R&D expense was 8% and 6%, respectively, of adjusted revenue (total revenue less contracts & grants).





    (in millions)
    Three Months Ended September 30,
    20202019% Change
    Research and Development Expenses$84.4$53.458%
    Adjustments:
    Less Contracts and Grants Revenue$25.9$35.6(27)%
    Less Impairment of IPR&D intangible asset$29.0$—NA
    Net Research and Development Expenses$29.5$17.866%
    Adjusted Revenue

    (Total Revenue less Contracts and Grants Revenue)
    $359.3$276.230%
    Net R&D as % of Adjusted Revenue (Net R&D Margin)8%6%NA

    Selling, General and Administrative

    For Q3 2020, selling, general and administrative expenses were $75.5 million, an increase of $10.5 million or 16% as compared to Q3 2019. The increase primarily reflects an increase in staffing costs to support the Company's growth.

    Amortization of Intangible Assets

    For Q3 2020, amortization of intangible assets was $15.0 million, which was consistent with amortization of intangible assets of $14.7 million in Q3 2019.

    Income Taxes

    For Q3 2020, the income tax provision was $15.5 million as compared to $15.7 million in Q3 2019. The decrease is due to a decrease in income before the provision for income taxes of $3.9 million, an increase in discrete tax benefits of $3.5 million, offset by the impact of non-deductible contingent consideration expense. The Company's effective quarterly tax rate, excluding discrete adjustments, was 34% and 26%, for Q3 2020 and Q3 2019, respectively. The effective quarterly tax rate, excluding the impact of non-deductible contingent consideration expense was 22% and 26%, for Q3 2020 and Q3 2019, respectively.

    Net Income & Adjusted Net Income

    For Q3 2020, the Company recorded net income of $39.5 million, or $0.73 per diluted share, versus net income of $43.2 million, or $0.83 per diluted share, in 2019.

    For Q3 2020, the Company recorded adjusted net income of $119.0 million, or $2.19 per diluted share, versus adjusted net income of $64.8 million, or $1.24 per diluted share, in 2019. (1)

    Adjusted EBITDA

    For Q3 2020, the Company recorded adjusted EBITDA of $168.1 million versus $106.4 million in 2019. (1)

    (II) Nine months ended September 30, 2020 (unaudited)

    Revenues

    Total Revenues

    For the nine months ended September 30, 2020, total revenues were $972.4 million, an increase of 30% over 2019. Total revenues reflect an increase in product sales and contract development and manufacturing services offset by a decrease in contracts and grants revenues.

    Product Sales

    For the nine months ended September 30, 2020, product sales were $648.9 million, an increase of $56.2 million or 9% as compared to 2019. Other product sales decreased due to a decline in sales of raxibacumab and travel health vaccines slightly offset by an increase in sales of BAT and VIGIV.





    (in millions)
    Nine Months Ended September 30,
    20202019% Change
    Product Sales
    Anthrax vaccines$258.1$79.9NM
    NARCAN® Nasal Spray$233.8$213.510%
    ACAM2000$71.0$164.1(57)%
    Other$86.0$135.2(36)%
    Total Product Sales$648.9$592.79%

    Contract Development and Manufacturing (CDMO) Services

    For the nine months ended September 30, 2020, revenue from the Company's contract development and manufacturing services operations was $251.4 million, an increase of $196.8 million as compared to 2019. The increase is largely due to the contribution of arrangements across development, drug substance manufacturing, and drug product manufacturing services with industry and government customers.

    Contracts and Grants

    For the nine months ended September 30, 2020, revenue from the Company's development-based contracts and grants was $72.1 million, a decrease of $26.3 million or 27% as compared to 2019. The decrease primarily reflects the completion of development activities associated with the AV7909 product candidate in 2019, offset by recent new development awards related to the Company's COVID-19 product candidates.

    Operating Expenses

    Cost of Product Sales and Contract Development and Manufacturing Services

    For the nine months ended September 30, 2020, cost of product sales and contract development and manufacturing services was $355.7 million, an increase of $55.0 million or 18% as compared to 2019. The increase is due primarily to an increase in volume of product sales and CDMO services, charges of $31.3 million related to the Company's contingent consideration liabilities, a charge of $13.8 million related to a write-down of inventory balances due to the expected expiration of a portion of the Company's travel health vaccines, and an increase in share-based compensation expense due to a one-time special broad-based, immediately vested equity award to employees.

    Research and Development (Gross and Net)

    For the nine months ended September 30, 2020, gross R&D expenses were $175.0 million, an increase of $11.6 million compared to 2019. The increase primarily reflects the impact of impairment of the Company's IPR&D intangible asset of $29.0 million. Excluding this item, gross R&D expense decreased $17.4 million compared to 2019. The decrease primarily reflects a decrease in costs in 2020 due to the completion of development activities associated with the Company's AV7909 product candidate in 2019. The decrease has been partially offset by an increase in costs associated with the Company's chikungunya and COVID-19 product candidates.

    For the nine months ended September 30, 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue and the impact of the IPR&D intangible asset impairment, was $73.9 million, an increase of $8.9 million or 14% as compared to 2019. The increase primarily reflects an increase in costs associated with the Company's chikungunya and COVID-19 product candidates offset by a decline in costs associated with the FLU-IGIV product candidate. The 2020 and 2019 net R&D expense was 8% and 10%, respectively, of adjusted revenue (total revenue less contracts & grants).





    (in millions)
    Nine Months Ended September 30,
    20202019% Change
    Research and Development Expenses$175.0$163.47%
    Adjustments:
    Less Contracts and Grants Revenue$72.1$98.4(27)%
    Less Impairment of IPR&D intangible asset$29.0$—NA
    Net Research and Development Expenses$73.9$65.014%
    Adjusted Revenue

    (Total Revenue less Contracts and Grants Revenue)
    $900.3$647.339%
    Net R&D as % of Adjusted Revenue (Net R&D Margin)8%10%NA

    Selling, General and Administrative

    For the nine months ended September 30, 2020, selling, general and administrative expenses were $221.2 million, an increase of $19.9 million or 10% as compared to 2019. The increase primarily reflects an increase in staffing costs to support the Company's growth and share-based compensation due to a special broad-based, immediately vested equity award to employees during the second quarter of 2020.

    Amortization of Intangible Assets

    For the nine months ended September 30, 2020, amortization of intangible assets of $44.8 million was consistent with $43.9 million in 2019.

    Income Taxes

    For the nine months ended September 30, 2020, the income tax provision of $34.7 million increased $36.4 million when compared to 2019. The increase is due to an increase in income before the provision for income taxes of $148.5 million, offset by an increase in discrete tax benefits of $7.0 million in 2020. The Company's effective tax rate, excluding discrete adjustments, was 29% and 27%, for the nine months ended September 30, 2020 and 2019, respectively. The effective tax rate, excluding the impact of non-deductible contingent consideration expense was 25% and 24%, for the nine months ended September 30, 2020 and 2019, respectively.

    Net Income & Adjusted Net Income

    For the nine months ended September 30, 2020, the Company recorded net income of $119.7 million, or $2.23 per diluted share, versus net income of $7.6 million, or $0.15 per diluted share, in 2019.

    For the nine months ended September 30, 2020, the Company recorded adjusted net income of $225.1 million, or $4.20 per diluted share, versus adjusted net income of $69.6 million, or $1.33 per diluted share, in 2019. (1)

    Adjusted EBITDA

    For the nine months ended September 30, 2020, the Company recorded adjusted EBITDA of $339.5 million versus $145.4 million in 2019. (1)

    2020 FINANCIAL FORECAST

    Based upon the Company's financial performance year to date as well as expectations for the remainder of the year, the Company has updated its full year 2020 financial forecast reflected by the following financial metrics and accompanying operational considerations:

    Financial Metrics

    (in millions)Updated 2020 FORECAST (As of 11/5/2020)Previous 2020 forecast (As of 7/30/2020)
    Total Revenues$1,520 - $1,580$1,500 - $1,600
    •   NARCAN® Nasal Spray$295 - $315$285 - $315
    •   Anthrax vaccines$350 - $370$320 - $350
    •   ACAM2000$160 - $200$180 - $200
    •   CDMO$450 - $470$440 - $460
    Adjusted Net Income (1)$375 - $405$340 - $390
    Adjusted EBITDA (1)$575 - $615$535 - $600

    The following operational considerations are incorporated in the Company's forecast and remain consistent with the previous forecast:

    • Year over year improvement in gross margin of 400 - 600 basis points driven by improved product mix and increased contribution from the Company's CDMO business;
    • The previously announced delay into 2021 of the launch of the Phase 3 clinical study for CHIKV-VLP, the Company's chikungunya virus virus-like particle vaccine, due to the timing of certain operational factors;
    • The continued deferral into 2021 of a follow-on procurement contract with the U.S. government for raxibacumab, the Company's FDA-approved anthrax monoclonal antibody therapeutic, due to the impact of the prioritization of Operation Warp Speed on the Company's technology transfer activities for the product;
    • Continued challenges through the end of 2020 in the Company's travel health business and revenues associated with Vaxchora® (Cholera Vaccine, Live, Oral) and Vivotif® (Typhoid Vaccine Live Oral Ty21a);
    • No generic competition in 2020 for NARCAN® Nasal Spray.

    The Company has assessed the risks to its business associated with the COVID-19 pandemic and has adopted measures to mitigate those risks as they are understood today and accordingly is providing this outlook for 2020. Despite the lack of expected material disruption to the business, the Company's executive management continues to assess the business and operational implications associated with the pandemic and market conditions on its employees, patients, and customers.

    The outlook for 2020 does not include estimates for potential new corporate development or other M&A transactions.

    FOOTNOTES

    (1) See "Reconciliation of Net Income to Adjusted Net Income and Adjusted EBITDA and Gross Margin and Adjusted Gross Margin" for a definition of terms and the reconciliation tables.

    CONFERENCE CALL, PRESENTATION SUPPLEMENT, AND WEBCAST INFORMATION

    Company management will host a conference call at 5:00 pm (Eastern Time) today, November 5, 2020, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company's website or through the following:

    Live Teleconference Information:

    Dial in: [US] (855) 766-6521; [International] (262) 912-6157

    Conference ID: 3549944

    Live Webcast Information:

    Visit https://edge.media-server.com/mmc/p/7c8i4shm for the live webcast feed.

    A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."

    ABOUT EMERGENT BIOSOLUTIONS INC.

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

    SAFE HARBOR STATEMENT

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, our financial guidance and related projections and statements regarding our ability to meet such projections in the anticipated timeframe, if at all; statements regarding executing our strategy; delivering on our commitments to our partners and customers; creating value for our shareholders; our ability to develop safe and effective vaccines against the novel strain of coronavirus (SARS-CoV-2) causing COVID-19 and implement measures to mitigate the risks to our business posed by COVID-19; total contract and related option value; annual improvement in gross margin driven by improved product and services mix; the lack of generic competition for NARCAN® Nasal Spray for the remainder of 2020; the expectation that the Company will meet its final sales milestone for NARCAN® Nasal Spray; the entry into a follow-on procurement contract for raxibacumab in 2021; the launch of a Phase 3 clinical study for CHIKV-VLP; the annual impact on our revenues from declines in sales of our vaccine products that target travelers due to the reduction of international travel caused by the COVID-19 pandemic and any other statements containing the words "will," "believes," "expects," "anticipates," "intends," "plans," "targets," "forecasts," "estimates" and similar expressions in conjunction with, among other things, discussions of the Company's outlook, financial performance or financial condition, financial and operation goals, strategic goals, growth strategy, product sales, government development or procurement contracts or awards, government appropriations, manufacturing capabilities, and the timing of certain regulatory approvals or expenditures are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate.

    Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statements speak only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the impact of global economic conditions and public health crises and epidemics, such as the impact from the global pandemic that arose from COVID-19, on the markets, our operations, and employees as well as those of our customers and suppliers; our ability to obtain or maintain FDA approval or authorization for emergency or broader patient use of our COVID-19 treatments and their actual safety and effectiveness; availability of U.S. government funding for procurement for our products and certain product candidates and the future exercise of options under contracts related to such procurement; the negotiation of further commitments or contracts related to the collaboration and deployment of capacity toward future commercial manufacturing under our CDMO contracts; our ability to perform under our contracts with the U.S. government and our CDMO clients, including the timing of and specifications relating to deliveries; the continued exercise of discretion by BARDA to procure additional doses of AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) prior to approval by the FDA; our ability to secure licensure of AV7909 from the FDA within the anticipated timeframe, if at all; our ability to secure follow-on procurement contracts for our solutions to public health threats that are under procurement contracts that have expired or will be expiring; our ability to successfully appeal the patent litigation decision related to NARCAN® Nasal Spray 4mg/spray; our ability and the ability of our collaborators to enforce patents related to NARCAN® Nasal Spray against potential generic entrants; our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria; our ability and the ability of our contractors and suppliers to maintain compliance with Current Good Manufacturing Practices and other regulatory obligations; our ability to comply with the operating and financial covenants required by our senior secured credit facilities and the indenture governing our senior unsecured notes due 2028; our ability to obtain and maintain regulatory approvals for our other product candidates and the timing of any such approvals; the procurement by government entities outside of the United States under regulatory exemptions prior to approval by the corresponding regulatory authorities in the applicable country; the success of our commercialization, marketing and manufacturing capabilities and strategy; and the accuracy of our estimates regarding future revenues, expenses, and capital requirements and needs for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission when evaluating our forward-looking statements.

    Investor Contact Media Contact
    Robert Burrows Miko B. Neri
    Vice President, Investor Relations Senior Director, Global Communications & Public Affairs
    (o) 240/631-3280; (m) 240/413-1917 (o) 240/631-3392
      



    Emergent BioSolutions Inc.

    Condensed Consolidated Balance Sheets

    (unaudited, in millions, except per share data)

    ASSETS September 30, 2020  December 31, 2019
    Current assets:     
    Cash and cash equivalents$415.0 $167.8
    Restricted cash 0.2  0.2
    Accounts receivable, net 196.1  270.7
    Inventories, net 270.1  222.5
    Prepaid expenses and other current assets 77.4  25.0
    Total current assets 958.8  686.2
     Property, plant and equipment, net

     606.5  542.3
    Intangible assets, net 678.1  712.9
    In-process research and development   29.0
    Goodwill 266.5  266.6
    Other assets 106.4  90.3
    Total assets$2,616.3 $2,327.3



    LIABILITIES AND STOCKHOLDERS' EQUITY       
    Current liabilities:       
    Accounts payable$102.8  $94.8 
    Accrued expenses 34.9   39.5 
    Accrued compensation 76.9   62.4 
    Debt, current portion 30.9   12.9 
    Other current liabilities 53.8   6.7 
    Total current liabilities 299.3   216.3 
            
    Contingent consideration, net of current portion 35.2   26.0 
    Debt, net of current portion 848.5   798.4 
    Deferred tax liability 64.0    63.9 
    Contract liabilities, net of current portion 60.4   85.6 
    Other liabilities 57.4   48.6 
    Total liabilities$1,364.8  $1,238.8 
    Stockholders' equity:       
    Preferred stock, $0.001 par value; 15.0 shares authorized, no shares issued or outstanding  —    — 
    Common stock, $0.001 par value; 200.0 shares authorized, 54.2 and 53.0 shares issued; 53.0 and 51.7 shares outstanding, respectively 0.1   0.1 
    Treasury stock, at cost, 1.2 common shares (39.6)  (39.6)
    Additional paid-in capital 770.9   716.1 
    Accumulated other comprehensive loss, net (21.4)  (9.9)
    Retained earnings

     541.5   421.8 
    Total stockholders' equity 1,251.5   1,088.5 
    Total liabilities and stockholders' equity$2,616.3  $2,327.3 



    Emergent BioSolutions Inc.

    Condensed Consolidated Statements of Operations

    (unaudited, in millions, except per share data)

      
     Three Months Ended September 30, Nine Months Ended September 30, 
    Revenues: 2020  2019  2020  2019 
    Product sales, net$202.2 $256.2 $648.9 $592.7 
    Contract development and manufacturing        
    services157.1 20.0 251.4 54.6 
    Contracts and grants25.9 35.6 72.1 98.4 
    Total revenues385.2 311.8 972.4 745.7 
    Operating expenses:    
    Cost of product sales and contract development and manufacturing services



    149.0
     



    108.0
     



    355.7
     



    300.7
     
    Research and development84.4 53.4 175.0 163.4 
    Selling, general and administrative75.5 65.0 221.2 201.3 
    Amortization of intangible assets15.0 14.7 44.8 43.9 
    Total operating expenses323.9 241.1 796.7 709.3 
             
    Income from operations61.3 70.7 175.7 36.4 
             
    Other income (expense):    
    Interest expense(7.6)(10.3)(22.6)(29.3)
    Other, net1.3 (1.5)1.3 (1.2)
    Total other income (expense), net(6.3)(11.8)(21.3)(30.5)
    Income before provision (benefit) for income taxes 55.0  58.9  154.4  5.9 
    Income tax provision (benefit) 15.5  15.7  34.7  (1.7)
    Net income$39.5 $43.2 $119.7 $7.6 
             
    Net income per common share        
    Basic$0.75 $0.84 $2.28 $0.15 
    Diluted$0.73 $0.83 $2.23 $0.15 
                 
    Shares used in computing income per share            
    Basic 53.0  51.6  52.5  51.4 
    Diluted 54.3  52.3  53.6  52.3 



    Emergent BioSolutions Inc.

    Condensed Consolidated Statements of Cash Flows

    (unaudited, in millions)

     Nine Months Ended September 30,
      2020  2019 
    Cash flows provided by operating activities:      
    Net income$        119.7 $        7.6 
    Adjustments to reconcile net income to net cash provided by operating activities:  
    Stock-based compensation expense 41.0  21.0 
    Depreciation and amortization 85.6  82.8 
    Impairment of IPR&D intangible asset 29.0   
    Change in fair value of contingent consideration, net 31.3  12.4 
    Amortization of deferred financing costs 2.4  2.2 
    Deferred income taxes (4.4) (5.7)
    Other 0.6  0.7 
    Changes in operating assets and liabilities:  
    Accounts receivable 74.6  (18.6)
    Inventories (47.6) (24.4)
    Prepaid expenses and other assets (61.8) (36.5)
    Accounts payable 10.6  2.5 
    Accrued expenses 4.4  5.2 
    Accrued compensation 14.5  (2.4)
    Contract liabilities (9.0) 19.1 
    Net cash provided by operating activities: 290.9  65.9 
    Cash flows used in investing activities:  
    Purchases of property, plant and equipment and other (105.0) (50.8)
    Milestone payment from prior asset acquisition (10.0) (10.0)
    Net cash used in investing activities: (115.0) (60.8)
    Cash flows provided by financing activities:

          
    Proceeds from revolving credit facility   130.0 
    Principal payments on revolving credit facility (373.0) (95.0)
    Proceeds from senior unsecured notes 450.0   
    Principal payments on term loan facility (8.4) (8.4)
    Debt issuance costs (8.4)  
    Proceeds from exercise of stock options 26.6  5.7 
    Taxes paid for share-based compensation activity (12.8) (6.6)
    Contingent consideration payments (2.2) (3.7)
    Net cash provided by financing activities: 71.8  22.0 
    Effect of exchange rate changes on cash, cash equivalents and restricted cash (0.5) (0.1)
    Net increase in cash, cash equivalents and restricted cash 247.2  27.0 
    Cash, cash equivalents and restricted cash at beginning of period 168.0  112.4 
    Cash, cash equivalents and restricted cash at end of period$        415.2 $        139.4 



    RECONCILIATION OF NET INCOME TO ADJUSTED NET INCOME AND ADJUSTED EBITDA and GROSS MARGIN AND ADJUSTED GROSS MARGIN (unaudited)

    This press release contains four financial measures (Adjusted Net Income, Adjusted EBITDA (Earnings Before Depreciation and Amortization, Interest and Taxes, Gross Margin and Adjusted Gross Margin)) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company's definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted net income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges. All adjustments are tax effected utilizing the federal statutory tax rate for the US, except for changes in the fair value of contingent consideration as the vast majority is non-deductible for tax purposes. Adjusted net income margin is defined as adjusted net income divided by total revenues. Adjusted EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and income tax provision (benefit), excluding specified items that can be highly variable and the non-cash impact of certain accounting adjustments. Adjusted EBITDA margin is defined as Adjusted EBITDA divided by total revenues. Gross margin reflects adjusted revenues minus cost of product sales and contract development and manufacturing services (COGS). Adjusted revenues is calculated as total revenues minus contracts and grants revenues. Gross margin percentage is calculated as gross margin divided by adjusted revenues. Adjusted gross margin adjusts COGS for specified items that can be highly variable or difficult to predict, or to reflect the non-cash impacts of charges (Adjusted COGS). Adjusted gross margin is calculated as adjusted revenues minus adjusted COGS. Adjusted gross margin percentage is calculated as adjusted gross margin divided by adjusted revenues. The Company views these non-GAAP financial measures as a means to facilitate management's financial and operational decision-making, including evaluation of the Company's historical operating results and comparison to competitors' operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company's operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure may provide a more complete understanding of factors and trends affecting the Company's business.

    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. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety.

    Reconciliation of Net Income to Adjusted Net Income (Unaudited)









    (in millions, except per share value)
    Three Months Ended September 30,
     2020  2019 Source
    Net income$39.5 $43.2  
    Adjustments:
    + Changes in fair value of contingent consideration 30.2  6.9 COGS
    + Impairment of IPR&D intangible asset 29.0   R&D
    + Exit and disposal costs* 17.1   COGS, SG&A, Other Income
    + Non-cash amortization charges 15.9  15.4 Intangible Asset Amortization, Other Income
    + Acquisition-related costs (transaction & integration) 0.5  3.2 SG&A
    Tax effect (13.2)  (3.9)  
    Total adjustments:$79.5 $21.6  
    Adjusted net income$119.0 $64.8  
    Adjusted net income per diluted share$2.19 $1.24  

    * Amount incorporates $13.8 million of inventory reserves associated with the Company's travel health vaccines









    (in millions, except per share value)
    Nine Months Ended September 30,
     2020  2019 Source
    Net income$119.7 $7.6  
    Adjustments:
    + Non-cash amortization charges 47.2  46.1 Intangible Asset Amortization, Other Income
    + Changes in fair value of contingent consideration 31.3  12.4 COGS
    + Impairment of IPR&D intangible asset 29.0   R&D
    + Exit and disposal costs* 17.1   COGS, SG&A, Other Income
    + Acquisition-related costs (transaction & integration) 0.5  10.6 SG&A
    + Impact of purchase accounting on inventory step-up   6.1 COGS
    Tax effect (19.7)  (13.2)  
    Total adjustments:$105.4 $62.0  
    Adjusted net income$225.1 $69.6  
    Adjusted net income per diluted share$4.20 $1.33  

    * Amount incorporates $13.8 million of inventory reserves associated with the Company's travel health vaccines









    (in millions)
    Updated 2020 Full Year Forecast
    2020FSource
    Net income$255 - $285 
    Adjustments:
    + Non-cash amortization charges63Intangible Asset Amortization,

    Other Income
    + Changes in fair value of contingent consideration32COGS
    + Impairment of IPR&D intangible asset29R&D
    + Exit and disposal costs17COGS, SG&A,

    Other

    Income
    + Acquisition-related costs (transaction & integration)1SG&A
    Tax effect(22) 
    Total adjustments:$120 
    Adjusted net income$375 - $405 



    Reconciliation of Net Income to Adjusted EBITDA (Unaudited)





    (in millions)
    Three Months Ended September 30,
     2020 2019
    Net income$39.5$43.2
    Adjustments:
    + Depreciation & amortization 28.8 27.7
    + Provision for income taxes 15.5 15.7
    + Total interest expense, net* 7.5 9.7
    + Changes in fair value of contingent consideration 30.2 6.9
    + Impairment of IPR&D intangible asset 29.0 
    + Exit and disposal costs** 17.1 
    + Acquisition-related costs (transaction & integration) 0.5 3.2
    Total adjustments$128.6$63.2
    Adjusted EBITDA             $168.1  $106.4
    * Includes interest income of $0.1 million in 2020 and $0.6 million in 2019

    ** Amount incorporates $13.8 million of inventory reserves associated with the Company's travel health vaccines







    (in millions)
    Nine Months Ended September 30,
     2020 2019 
    Net income$119.7$7.6 
    Adjustments:
    + Depreciation & amortization 85.6 82.8 
    + Provision (benefit) for (from) income taxes 34.7 (1.7) 
    + Total interest expense, net* 21.6 27.6 
    + Changes in fair value of contingent consideration 31.3 12.4 
    + Impairment of IPR&D intangible asset 29.0  
    + Exit and disposal costs** 17.1  
    + Acquisition-related costs (transaction & integration) 0.5 10.6 
    + Impact of purchase accounting on inventory step-up  6.1 
    Total adjustments$        219.8$        137.8 
    Adjusted EBITDA$339.5$145.4 
    * Includes interest income of $1.0 million in 2020 and $1.7 million in 2019

    ** Amount incorporates $13.8 million of inventory reserves associated with the Company's travel health vaccines











    (in millions)
    Updated 2020 Full Year Forecast
    2020F
    Net income$255 - $285
    Adjustments: 
    + Depreciation & amortization115
    + Provision for income taxes96 - 106
    + Total interest expense30
    + Change in fair value of contingent consideration32
    + Impairment of IPR&D intangible asset29
    + Exit and disposal costs17
    + Acquisition-related costs (transaction and integration)1
    Total adjustments$320 - $330
    Adjusted EBITDA$575 - $615

    Reconciliation of Gross Margin and Adjusted Gross Margin (Unaudited)









    (in millions)
    Three Months Ended September 30,Nine Months Ended September 30,
     2020  2019  2020  2019 
    Total revenues$385.2 $311.8 $972.4 $745.7 
    Less: Contract and grants revenues (25.9)  (35.6)  (72.1)  (98.4) 
    Adjusted revenues$359.3 $276.2 $900.3 $647.3 
       
    Cost of product sales and contract development and manufacturing services ("COGS")$149.0 $108.0 $355.7 $300.7 
    - Changes in fair value of contingent consideration (30.2)  (6.9)  (31.3)  (12.4) 
    - Inventory reserves related to Travel Health vaccines (13.8)    (13.8)   
    Adjusted COGS$105.0 $101.1 $310.6 $288.3 
       
    Gross margin (adjusted revenues minus COGS)$210.3 $168.2 $544.6 $346.6 
    Gross margin % (gross margin divided by adjusted revenues) 59%  61%  60%  54% 
     
    Adjusted gross margin (adjusted revenues minus adjusted COGS)$254.3 $175.1 $589.7 $359.0 
    Adjusted gross margin % (adjusted gross margin divided by adjusted revenues) 71%  63%  66%  55% 



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  5. GAITHERSBURG, Md., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) will host a conference call on Thursday, November 5, 2020 at 5:00 pm (Eastern Time) to discuss the financial results for the third quarter of 2020, recent business developments, revenue guidance for the fourth quarter of 2020, and financial outlook for full year 2020.

    This conference call can be accessed live by telephone or by webcast:

    Live Teleconference Information:
    Dial in number: (855) 766-6521
    International dial in number: (262) 912-6157
    Conference ID: 3549944

    Live Webcast Information:
    Visit https://edge.media-server.com/mmc/p/7c8i4shm for the live webcast feed.

    A replay of the call can be accessed on Emergent's website emergentbiosolutions.com

    GAITHERSBURG, Md., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) will host a conference call on Thursday, November 5, 2020 at 5:00 pm (Eastern Time) to discuss the financial results for the third quarter of 2020, recent business developments, revenue guidance for the fourth quarter of 2020, and financial outlook for full year 2020.

    This conference call can be accessed live by telephone or by webcast:

    Live Teleconference Information:

    Dial in number: (855) 766-6521

    International dial in number: (262) 912-6157

    Conference ID: 3549944

    Live Webcast Information:

    Visit https://edge.media-server.com/mmc/p/7c8i4shm for the live webcast feed.

    A replay of the call can be accessed on Emergent's website emergentbiosolutions.com under "Investors."

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280



    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

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    • NIAID has initiated a Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including Emergent's COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19
    • Emergent is planning additional clinical trials to evaluate COVID-HIG for potential use in other patient populations or individuals at high risk of exposure

    GAITHERSBURG, Md., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of the Phase 3 clinical trial that will evaluate plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with coronavirus disease (COVID-19). The INSIGHT-013 clinical study called…

    • NIAID has initiated a Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including Emergent's COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19
    • Emergent is planning additional clinical trials to evaluate COVID-HIG for potential use in other patient populations or individuals at high risk of exposure

    GAITHERSBURG, Md., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of the Phase 3 clinical trial that will evaluate plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with coronavirus disease (COVID-19). The INSIGHT-013 clinical study called "Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)," is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study will evaluate the safety, tolerability, and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19. The randomized controlled clinical trial assigns participants to receive infusions of either a placebo or one of four hyperimmune globulin products, which includes Emergent's COVID-HIG, with a background therapy of remdesivir in all groups.

    "Emergent is proud to continue our partnership with NIAID/NIH and the Biomedical Advanced Research and Development Authority (BARDA) to advance potential therapeutic solutions for COVID-19 in hospitalized patients," said Dr. Laura Saward, SVP and therapeutics business unit head at Emergent BioSolutions. "We are drawing from decades of experience developing treatments on our well-established hyperimmune platform to address this serious public health threat."

    Emergent is one of four companies providing hyperimmune globulin products for the trial, which plans to enroll approximately 500 patients across U.S. and international clinical trial sites. The ITAC investigators will assess whether giving people anti-coronavirus hyperimmune globulin at the onset of COVID-19 symptoms could augment the natural—and possibly delayed—antibody response to SARS-CoV-2, thereby potentially reducing the risk of more serious illness and death. The main goal of the trial is to compare the health status of participants treated with hyperimmune globulin plus remdesivir with participants treated with a placebo plus remdesivir. Remdesivir, an investigational broad-spectrum antiviral, was developed by Gilead Sciences, Inc.

    Emergent's COVID-HIG is being developed as a potential treatment for hospitalized patients as well as high-risk, acute symptomatic patients with $14.5 million in funding from BARDA, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. COVID-HIG will also be evaluated as a potential post-exposure prophylaxis (PEP) therapeutic in populations at high risk of exposure to SARS-CoV-2, such as front-line health care workers and military service members, with funding from the U.S. Department of Defense. The Investigational New Drug (IND) application to enable use of COVID-HIG in the ITAC study was submitted to the U.S. Food and Drug Administration (FDA) and subsequently cleared in August. The IND supports use of COVID-HIG in NIAID's current ITAC trial and will also support the additional treatment and PEP indications to be investigated in future clinical studies.

    For more information about the ITAC trial, visit the posting on clinicaltrials.gov.

    About Hyperimmune Globulin

    Hyperimmune globulin, also referred to as polyclonal antibodies, is a concentrated antibody product derived from the antibody-rich plasma of people who were previously infected with and recovered from an illness; in this case, COVID-19 caused by the virus SARS-CoV-2. In order to produce plasma-derived products, plasma is collected from a pool of human donors and then manufactured, or fractionated, into specialized therapeutic products.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

    Emergent's Response to COVID-19

    Emergent BioSolutions is deploying its decades of experience in vaccine and hyperimmune development and manufacturing, as well as its molecule-to-market contract development and manufacturing (CDMO) services to provide comprehensive medical countermeasure solutions in response to the COVID-19 pandemic.

    Using its established hyperimmune platforms, Emergent is developing two investigational plasma-based treatments - COVID-19 Human Immune Globulin (COVID-HIG) and COVID-Equine Immune Globulin (COVID-EIG). COVID-HIG is being developed as a human plasma-derived therapy candidate with $14.5 million in HHS funding and will be evaluated in two studies, inclusive of INSIGHT-13 (ITAC), of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for potential treatment of COVID-19 in severe hospitalized and high-risk patients. With $34.6 million in funding from the Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, and in collaboration with the Mount Sinai Health System and ImmunoTek Bio Centers, COVID-HIG will also be evaluated for post-exposure prophylaxis in populations at high risk of COVID-19, such as front-line health care workers and the military. COVID-EIG is being developed as an equine plasma-derived therapy candidate for potential treatment of severe disease in humans. Both candidates are anticipated to be in clinical studies in 2020 and 2021. These investigational products are not approved by the U.S. Food and Drug Administration and their safety and effectiveness have not been established.

    Emergent is deploying its CDMO capabilities, capacities, and expertise to support the U.S. government's Operation Warp Speed to pave the way for innovators to advance COVID-19 programs. The company is working with four innovators to develop and manufacture COVID-19 vaccine candidates. For the COVID-19 vaccine response, Emergent's integrated CDMO network provides development services from its Gaithersburg facility, drug substance manufacturing at its Baltimore Bayview facility, and drug product manufacturing at its Baltimore Camden and Rockville facilities, all in Maryland.

    For 22 years Emergent has focused on advancing public health, and its multi-pronged approach to tackling COVID-19 demonstrates its commitment to its mission – to protect and enhance life.

    Safe Harbor Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the ability of COVID-HIG to effectively treat hospitalized patients with COVID-19, as well as high-risk, acute symptomatic patients and to become an effective PEP therapeutic for groups at high risk of developing COVID-19, and the ability of COVID-EIG to treat severe disease in humans, as well as statements regarding planned clinical trials, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

    There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the overall success of the collaboration and planned development programs; our ability to maintain a sufficient level of convalescent plasma; the results of planned clinical trials and the timing of and our ability to obtain and maintain regulatory authorizations for emergency or broader patient use or approvals; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

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  6. DUBLIN, Sept. 2, 2020 /PRNewswire/ -- The "Viral Vector Manufacturing Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.

    Research and Markets Logo

    The global viral vector manufacturing market is projected to grow at a CAGR of 22.09% to reach a market size of US$1,469.144 million in 2025 from US$443.592 million in 2019.

    The viral vector market is primarily being driven by the growing adoption of adenoviral vectors, lentiviral vectors, as well as retroviral vectors. The growing adoption stems from the need for effectively transferring therapeutic gene into the target cells that are an integral part of the process that involves the insertion of a functional copy of a gene into a defective cell one of the preferred treatment…

    DUBLIN, Sept. 2, 2020 /PRNewswire/ -- The "Viral Vector Manufacturing Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.

    Research and Markets Logo

    The global viral vector manufacturing market is projected to grow at a CAGR of 22.09% to reach a market size of US$1,469.144 million in 2025 from US$443.592 million in 2019.



    The viral vector market is primarily being driven by the growing adoption of adenoviral vectors, lentiviral vectors, as well as retroviral vectors. The growing adoption stems from the need for effectively transferring therapeutic gene into the target cells that are an integral part of the process that involves the insertion of a functional copy of a gene into a defective cell one of the preferred treatment options for most chronic diseases, which is known as Gene therapy.



    Furthermore, the growing number of clinical trials, the increasing number of gene therapy, and the expanding cognizance of effective mode of disease treatment are further expected to drive the growth of the viral vector manufacturing market during the forecast period. Since vector designing, production, packaging, and release testing is subject to limited availability and faced with challenges due to the complex nature of technologies and platform and thus many players in this space often endeavor in striking strategic collaboration and acquisitions that cover many aspects like the delivery of clinical grade product under its ambit, to facilitate the successful collaboration development of viral agent-based products.



    Moreover, the efficient ability to express the therapeutic genes and non-pathogenic nature is another factor that is responsible for driving the growth of this market. The other key factors that are expected to drive the growth of the market are the increasing investment in the biopharmaceutical production coupled with the growing aging population, healthcare expenditure, technological advancement, especially in the genetic engineering segment.



    Moreover, the increasing accessibility of healthcare facilities, the growing demand for treatment of disease due to the increasing global burden of diseases are a few of the other factors that are poised to drive the growth of this market during the forecast period. Nevertheless, despite the transitioning of this niche industry to high manufacturing is one such factor that may restrain the growth of the market to a certain extent.



    Therefore, with such growing recognition of the importance of viral vectors, various developments are taking place in the viral vector manufacturing market. For instance, in June 2020, it was announced by Emergent BioSolutions Inc. (NYSE:EBS) which is a global life sciences company that it is going to invest $75 Million in Canton Site and expand viral vector and gene therapy capability facilitating the reinforcement of its contract development and manufacturing (CDMO) capabilities.



    Again, in June 2020, Oxford Biomedica (LSE: OXB) which is a major gene and cell therapy group, announced that it has signed an agreement of collaboration with the Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organization that has been established to provide the first strategic vaccine development and progressive manufacturing capability in the UK. Under this 5-year agreement, the organization will work towards enabling the manufacture of vaccines that are based on viral vector, to contribute towards a swift growth in the domestic capacity for this specialized field of vaccine manufacturing.



    In April 2020, Merck KGaA (FWB: MRK) a leading science and technology company announced that a 100 million facility, second in Carlsbad, California USA that is intended to boost its BioReliance viral and gene therapy service offering to help their customers to aid their customers to commercialize the gene therapies that are brought about by viral vectors concomitantly helping innovators scale up their production that is in tandem with the quantum that allows them to reach out to more patients.



    Earlier, in January 2020, the launch of ZYNTEGLO (autologous CD34+ cells encoding A-T87Q-globin gene) in Germany was announced by bluebird bio, Inc. (NASDAQ:BLUE). ZYNTEGLO is a one-time gene therapy that has been specifically developed for patients aged 12 years and older with transfusion-dependent -thalassemia (TDT) who do not possess 0/0 genotype.



    In December 2019, it was announced that a leading supplier of services and technologies for the life sciences industry called Novasep launched oXYgene which is a fully integrated offering for the construction of facilities dedicated towards customers to aid them in their viral vector production.



    In October 2019, it was reported that GE Healthcare Life Sciences which has now rebranded itself as Cytiva, was about to launch the KUBio box which is an adaptable, flexible and fully integrated environment for biomanufacturing to accelerate the production gene therapies based on of viral vector. These latest additions were intended to bring gene therapies swiftly to the market thereby contributing to the increased capacity in the viral vector area.



    In March 2018, it was reported that Sartorius Stedim Biotech SA (SSB), which is a major international technology partner supplier of products and services biopharmaceutical industry has been selected by ABL Europe as its chief supplier of single-use systems whereby the new viral vector manufacturing capacity has been started in Strasbourg at its European facility. ABL Europe, a subsidiary of ABL Inc. provides dedicated viral vector GMP manufacturing services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch.



    Key Topics Covered



    1. Introduction

    1.1. Market Definition

    1.2. Market Segmentation



    2. Research Methodology

    2.1. Research Data

    2.2. Assumptions



    3. Executive Summary

    3.1. Research Highlights



    4. Market Dynamics

    4.1. Market Drivers

    4.2. Market Restraints

    4.3. Porters Five Forces Analysis

    4.4. Industry Value Chain Analysis



    5. Viral Vector Manufacturing Market Analysis, By Type

    5.1. Introduction

    5.2. Retroviral vectors

    5.3. Lentiviral Vectors

    5.4. Adenoviral Vectors

    5.5. Others



    6. Viral Vector Manufacturing Market Analysis, By Application

    6.1. Introduction

    6.2. Vaccinology

    6.3. Gene Therapy



    7. Viral Vector Manufacturing Market Analysis, By End-User

    7.1. Introduction

    7.2. Pharmaceutical & Biotechnology Companies

    7.3. Research Institutes

    7.4. Contract Research Organizations



    8. Viral Vector Manufacturing Market Analysis, by Geography

    8.1. Introduction

    8.2. North America

    8.3. South America

    8.4. Europe

    8.5. The Middle East & Africa

    8.6. Asia-Pacific



    9. Competitive Environment and Analysis

    9.1. Major Players and Strategy Analysis

    9.2. Emerging Players and Market Lucrativeness

    9.3. Mergers, Acquisitions, Agreements, and Collaborations

    9.4. Vendor Competitiveness Matrix



    10. Company Profiles

    10.1. Sirion-Biotech GmbH

    10.2. Vigene Biosciences

    10.3. Batavia Biosciences B.V.

    10.4. Virovek

    10.5. Lonza

    10.6. Vector Biolabs

    10.7. Cobra Biologics

    10.8. MaxCyte, Inc.

    10.9. Genelux

    10.10. BioNTech SE



    For more information about this report visit https://www.researchandmarkets.com/r/dozt6p

    Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

    Media Contact:

    Research and Markets

    Laura Wood, Senior Manager

    andmarkets.com



    For E.S.T Office Hours Call +1-917-300-0470

    For U.S./CAN Toll Free Call +1-800-526-8630

    For GMT Office Hours Call +353-1-416-8900



    U.S. Fax: 646-607-1907

    Fax (outside U.S.): +353-1-481-1716





    Cision View original content:http://www.prnewswire.com/news-releases/global-viral-vector-manufacturing-market-2020-2025-growing-adoption-of-adenoviral-vectors-lentiviral-vectors-as-well-as-retroviral-vectors-301122912.html

    SOURCE Research and Markets

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  7. Dublin, Aug. 31, 2020 (GLOBE NEWSWIRE) -- The "Viral Vector Manufacturing Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.

    The global viral vector manufacturing market is projected to grow at a CAGR of 22.09% to reach a market size of US$1,469.144 million in 2025 from US$443.592 million in 2019.

    The viral vector market is primarily being driven by the growing adoption of adenoviral vectors, lentiviral vectors, as well as retroviral vectors. The growing adoption stems from the need for effectively transferring therapeutic gene into the target cells that are an integral part of the process that involves the insertion of a functional copy of a gene into a defective cell one of the preferred treatment…

    Dublin, Aug. 31, 2020 (GLOBE NEWSWIRE) -- The "Viral Vector Manufacturing Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.



    The global viral vector manufacturing market is projected to grow at a CAGR of 22.09% to reach a market size of US$1,469.144 million in 2025 from US$443.592 million in 2019.



    The viral vector market is primarily being driven by the growing adoption of adenoviral vectors, lentiviral vectors, as well as retroviral vectors. The growing adoption stems from the need for effectively transferring therapeutic gene into the target cells that are an integral part of the process that involves the insertion of a functional copy of a gene into a defective cell one of the preferred treatment options for most chronic diseases, which is known as Gene therapy.



    Furthermore, the growing number of clinical trials, the increasing number of gene therapy, and the expanding cognizance of effective mode of disease treatment are further expected to drive the growth of the viral vector manufacturing market during the forecast period. Since vector designing, production, packaging, and release testing is subject to limited availability and faced with challenges due to the complex nature of technologies and platform and thus many players in this space often endeavor in striking strategic collaboration and acquisitions that cover many aspects like the delivery of clinical grade product under its ambit, to facilitate the successful collaboration development of viral agent-based products.



    Moreover, the efficient ability to express the therapeutic genes and non-pathogenic nature is another factor that is responsible for driving the growth of this market. The other key factors that are expected to drive the growth of the market are the increasing investment in the biopharmaceutical production coupled with the growing aging population, healthcare expenditure, technological advancement, especially in the genetic engineering segment.



    Moreover, the increasing accessibility of healthcare facilities, the growing demand for treatment of disease due to the increasing global burden of diseases are a few of the other factors that are poised to drive the growth of this market during the forecast period. Nevertheless, despite the transitioning of this niche industry to high manufacturing is one such factor that may restrain the growth of the market to a certain extent.



    Therefore, with such growing recognition of the importance of viral vectors, various developments are taking place in the viral vector manufacturing market. For instance, in June 2020, it was announced by Emergent BioSolutions Inc. (NYSE:EBS) which is a global life sciences company that it is going to invest $75 Million in Canton Site and expand viral vector and gene therapy capability facilitating the reinforcement of its contract development and manufacturing (CDMO) capabilities.



    Again, in June 2020, Oxford Biomedica (LSE: OXB) which is a major gene and cell therapy group, announced that it has signed an agreement of collaboration with the Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organization that has been established to provide the first strategic vaccine development and progressive manufacturing capability in the UK. Under this 5-year agreement, the organization will work towards enabling the manufacture of vaccines that are based on viral vector, to contribute towards a swift growth in the domestic capacity for this specialized field of vaccine manufacturing.



    In April 2020, Merck KGaA (FWB: MRK) a leading science and technology company announced that a 100 million facility, second in Carlsbad, California USA that is intended to boost its BioReliance viral and gene therapy service offering to help their customers to aid their customers to commercialize the gene therapies that are brought about by viral vectors concomitantly helping innovators scale up their production that is in tandem with the quantum that allows them to reach out to more patients.



    Earlier, in January 2020, the launch of ZYNTEGLO (autologous CD34+ cells encoding A-T87Q-globin gene) in Germany was announced by bluebird bio, Inc. (NASDAQ:BLUE). ZYNTEGLO is a one-time gene therapy that has been specifically developed for patients aged 12 years and older with transfusion-dependent -thalassemia (TDT) who do not possess 0/0 genotype.



    In December 2019, it was announced that a leading supplier of services and technologies for the life sciences industry called Novasep launched oXYgene which is a fully integrated offering for the construction of facilities dedicated towards customers to aid them in their viral vector production.



    In October 2019, it was reported that GE Healthcare Life Sciences which has now rebranded itself as Cytiva, was about to launch the KUBio box which is an adaptable, flexible and fully integrated environment for biomanufacturing to accelerate the production gene therapies based on of viral vector. These latest additions were intended to bring gene therapies swiftly to the market thereby contributing to the increased capacity in the viral vector area.



    In March 2018, it was reported that Sartorius Stedim Biotech SA (SSB), which is a major international technology partner supplier of products and services biopharmaceutical industry has been selected by ABL Europe as its chief supplier of single-use systems whereby the new viral vector manufacturing capacity has been started in Strasbourg at its European facility. ABL Europe, a subsidiary of ABL Inc. provides dedicated viral vector GMP manufacturing services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch.



    Key Topics Covered



    1. Introduction

    1.1. Market Definition

    1.2. Market Segmentation



    2. Research Methodology

    2.1. Research Data

    2.2. Assumptions



    3. Executive Summary

    3.1. Research Highlights



    4. Market Dynamics

    4.1. Market Drivers

    4.2. Market Restraints

    4.3. Porters Five Forces Analysis

    4.4. Industry Value Chain Analysis



    5. Viral Vector Manufacturing Market Analysis, By Type

    5.1. Introduction

    5.2. Retroviral vectors

    5.3. Lentiviral Vectors

    5.4. Adenoviral Vectors

    5.5. Others



    6. Viral Vector Manufacturing Market Analysis, By Application

    6.1. Introduction

    6.2. Vaccinology

    6.3. Gene Therapy



    7. Viral Vector Manufacturing Market Analysis, By End-user

    7.1. Introduction

    7.2. Pharmaceutical & Biotechnology Companies

    7.3. Research Institutes

    7.4. Contract Research Organizations



    8. Viral Vector Manufacturing Market Analysis, by Geography

    8.1. Introduction

    8.2. North America

    8.3. South America

    8.4. Europe

    8.5. The Middle East & Africa

    8.6. Asia-Pacific



    9. Competitive Environment and Analysis

    9.1. Major Players and Strategy Analysis

    9.2. Emerging Players and Market Lucrativeness

    9.3. Mergers, Acquisitions, Agreements, and Collaborations

    9.4. Vendor Competitiveness Matrix



    10. Company Profiles

    10.1. Sirion-Biotech GmbH

    10.2. Vigene Biosciences

    10.3. Batavia Biosciences B.V.

    10.4. Virovek

    10.5. Lonza

    10.6. Vector Biolabs

    10.7. Cobra Biologics

    10.8. MaxCyte, Inc.

    10.9. Genelux

    10.10. BioNTech SE



    For more information about this report visit https://www.researchandmarkets.com/r/w8y0mk

    Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

    CONTACT: ResearchAndMarkets.com
             Laura Wood, Senior Press Manager
             
             For E.S.T Office Hours Call 1-917-300-0470
             For U.S./CAN Toll Free Call 1-800-526-8630
             For GMT Office Hours Call +353-1-416-8900
    

    Primary Logo

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  8. GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it is teaming up with the Boston Red Sox, Cincinnati Reds, Philadelphia Phillies, and Mothers Against Prescription Drug Abuse (MAPDA) to highlight the importance of potentially lifesaving overdose reversal medicines on International Overdose Awareness Day 2020. International Overdose Awareness Day is a global event held on August 31 each year that aims to raise awareness of overdose and reduce the stigma of drug-related deaths. Emergent, in collaboration with these teams and MAPDA, will address the importance of accessing overdose reversal medicines through special announcements, videos, and stadium presentations.

    "Emergent is committed…

    GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it is teaming up with the Boston Red Sox, Cincinnati Reds, Philadelphia Phillies, and Mothers Against Prescription Drug Abuse (MAPDA) to highlight the importance of potentially lifesaving overdose reversal medicines on International Overdose Awareness Day 2020. International Overdose Awareness Day is a global event held on August 31 each year that aims to raise awareness of overdose and reduce the stigma of drug-related deaths. Emergent, in collaboration with these teams and MAPDA, will address the importance of accessing overdose reversal medicines through special announcements, videos, and stadium presentations.

    "Emergent is committed to doing everything we can to increase awareness, access, and availability of potentially lifesaving overdose reversal medicines," said Doug White, SVP and devices business unit head at Emergent BioSolutions. "We are proud to team up with the Boston Red Sox, Cincinnati Reds, Philadelphia Phillies, and MAPDA on International Overdose Awareness Day to highlight the important role that overdose reversal medicines play in preparing individuals and families in the event of an accidental opioid overdose. Everyone can take a stand and take action by talking to their doctor or pharmacists about having immediate access to overdose reversal medicines."

    "By increasing awareness about the importance of having immediate access to overdose reversal medicines, we may empower individuals to be prepared in the event of an opioid overdose emergency," said Mary Bono, former U.S. Congresswoman and chairman and CEO of MAPDA. "MAPDA is honored to stand alongside Emergent, the Boston Red Sox, Cincinnati Reds, and Philadelphia Phillies, to help more individuals know about and access potentially lifesaving medicines to treat opioid overdoses."

    For more information, visit: www.cutoutoverdoses.com.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030.

    About MAPDA

    Mothers Against Prescription Drug Abuse (MAPDA) is a nonprofit consumer organization started by three mothers who lost children to prescription drug overdoses. The organization aims to prevent prescription drug abuse before it starts and support individuals in recovery. Mary Bono, a well-known political speaker and consumer advocate, now heads up the organization headquartered in the Washington DC suburbs. Learn more at MAPDA.net.

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

     

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

      

    Primary Logo

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  9. GAITHERSBURG, Md., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company's board of directors appointed Marvin L. White as a Class II director to serve on the board effective October 1, 2020, with an initial term expiring at the 2023 annual meeting of stockholders. Mr. White was also appointed as a member of both the Scientific Review Committee and Strategic Operations Committee of the board.

    "We welcome Marvin back to Emergent's Board of Directors," said Fuad El-Hibri, executive chairman of the board of Emergent BioSolutions. "He brings invaluable financial and management expertise gained from his time in the pharmaceutical and healthcare sectors. We look forward to his contributions in…

    GAITHERSBURG, Md., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company's board of directors appointed Marvin L. White as a Class II director to serve on the board effective October 1, 2020, with an initial term expiring at the 2023 annual meeting of stockholders. Mr. White was also appointed as a member of both the Scientific Review Committee and Strategic Operations Committee of the board.

    "We welcome Marvin back to Emergent's Board of Directors," said Fuad El-Hibri, executive chairman of the board of Emergent BioSolutions. "He brings invaluable financial and management expertise gained from his time in the pharmaceutical and healthcare sectors. We look forward to his contributions in advising company leadership on how to further grow and increase shareholder value."

    "I am delighted to serve on the board of a mission-driven organization focused on public health," said Mr. White. "As Emergent executes on its growth strategy, I embrace the opportunity to work with my distinguished colleagues on the board as well as the management team to help move the company forward."   

    Mr. White has served as president and chief executive officer and member of the board of directors of Aptevo Therapeutics Inc. since August 2016. He previously served on Emergent's board from 2010 to 2016. Prior to that, he served as chief financial officer of St. Vincent Health and was responsible for finance, patient financial services, and managed care for 19 hospitals and 36 joint ventures. Previously, he was chief financial officer of Lilly USA, a subsidiary of Eli Lilly and Company, where he also held leadership positions in Corporate Finance and Investment Banking. 

    Prior to his career in healthcare, Mr. White held leadership positions at General Motors, Hewlett-Packard, and Motorola, including financial roles for its Japan, South Asia and Latin America Cellular Group. He currently serves on the board of OneAmerica Financial Insurance Partners, Inc. Mr. White earned his Bachelor of Science degree in Accounting from Wilberforce University and his Master of Business Administration in Finance from Indiana University.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

    Safe Harbor Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, but no limited to, statements regarding executing on our growth strategy and increasing shareholder value, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission when evaluating our forward-looking statements.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

     

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

    Primary Logo

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  10. GAITHERSBURG, Md., Aug. 18, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that members of the company's executive management team will participate in the following virtual investor conferences through the end of September 2020:

    • 2020 NYSE Healthcare & Technology Investor Access Day
      August 18 – virtual one-on-one meetings only
       
    • 2020 Three Part Advisors Virtual Midwest IDEAS Investor Conference
      August 27 – pre-recorded presentation available beginning at 8:00am eastern
       
    • 2020 Wells Fargo Virtual Healthcare Conference
      September 9 – presentation at 8:00am eastern

    • Robert W. Baird 2020 Global Healthcare Conference
      September 10 – presentation at 2:35pm eastern

    • Morgan Stanley 18th Annual Global Healthcare Conference 2020

    GAITHERSBURG, Md., Aug. 18, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that members of the company's executive management team will participate in the following virtual investor conferences through the end of September 2020:

    • 2020 NYSE Healthcare & Technology Investor Access Day

      August 18 – virtual one-on-one meetings only

       
    • 2020 Three Part Advisors Virtual Midwest IDEAS Investor Conference

      August 27 – pre-recorded presentation available beginning at 8:00am eastern

       
    • 2020 Wells Fargo Virtual Healthcare Conference

      September 9 – presentation at 8:00am eastern



    • Robert W. Baird 2020 Global Healthcare Conference

      September 10 – presentation at 2:35pm eastern



    • Morgan Stanley 18th Annual Global Healthcare Conference 2020

      September 14 – presentation at 4:30pm eastern



    • Cantor Virtual Global Healthcare Conference 2020

      September 15 – presentation at 3:20pm eastern



    • 2020 Singular Research Compelling Values Webcall

      September 17 – presentation at 12:00pm eastern

    For conferences where a presentation is planned, the company's webcast presentation may include a discussion of the company's recent business developments as well as its financial results and guidance. The webcasts will be available both live, if possible, and by replay, and will be accessible from the Emergent website www.emergentbiosolutions.com under "Investors."

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

     

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

    Primary Logo

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  11. GAITHERSBURG, Md., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the shelf life of NARCAN® (naloxone HCl) Nasal Spray from 24 months to 36 months. Narcan Nasal Spray was the first intranasal form of naloxone approved by FDA and Health Canada for the emergency treatment of known or suspected opioid overdose.

    "Emergent is pleased to receive FDA approval of the shelf life extension for NARCAN® Nasal Spray," said Doug White, SVP and devices business unit head at Emergent. "This is an example of our continued efforts to innovate and improve product features designed to address the needs of patients, consumers, health care providers…

    GAITHERSBURG, Md., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the shelf life of NARCAN® (naloxone HCl) Nasal Spray from 24 months to 36 months. Narcan Nasal Spray was the first intranasal form of naloxone approved by FDA and Health Canada for the emergency treatment of known or suspected opioid overdose.

    "Emergent is pleased to receive FDA approval of the shelf life extension for NARCAN® Nasal Spray," said Doug White, SVP and devices business unit head at Emergent. "This is an example of our continued efforts to innovate and improve product features designed to address the needs of patients, consumers, health care providers, pharmacists, and first responders."

    In early July, the company launched the Generation II NARCAN® Nasal Spray device, which is identified by a red plunger and enhances temperature excursions and storage below 25°C.

    About NARCAN® Nasal Spray 4mg

    NARCAN® Nasal Spray 4mg is the first and only FDA-approved, needle-free presentation of naloxone for the emergency treatment of a known or suspected opioid overdose. It does not require assembly or any specialized medical training and is also the highest concentrated dose of intranasal naloxone currently available. NARCAN® Nasal Spray is not a substitute for emergency medical care, and additional doses of NARCAN® Nasal Spray may be required until emergency medical assistance arrives. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

    Please see Indications and Important Safety Information below.

    INDICATION AND IMPORTANT SAFETY INFORMATION FOR NARCAN NASAL SPRAY

    What is NARCAN Nasal Spray?

    • NARCAN Nasal Spray is a prescription medicine used for the emergency treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.



    • NARCAN Nasal Spray is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after giving the first dose of NARCAN Nasal Spray, even if the person wakes up.

    NARCAN Nasal Spray is safe and effective in children for known or suspected opioid overdose.

    Who should not use NARCAN Nasal Spray?

    Do not use NARCAN Nasal Spray if you are allergic to naloxone hydrochloride or any of the ingredients in NARCAN Nasal Spray.

    What is the most important information I should know about NARCAN Nasal Spray? NARCAN Nasal Spray is used to temporarily reverse the effects of opioid medicines. The medicine in NARCAN Nasal Spray has no effect in people who are not taking opioid medicines. Always carry NARCAN Nasal Spray with you in case of an opioid overdose.

    1. Use NARCAN Nasal Spray right away if you or your caregiver think signs or symptoms of an opioid overdose are present, even if you are not sure, because an opioid overdose can cause severe injury or death. Signs and symptoms of an opioid overdose may include:



      • unusual sleepiness and you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum)



      • breathing problems including slow or shallow breathing in someone difficult to awaken or who looks like they are not breathing



      • the black circle in the center of the colored part of the eye (pupil) is very small, sometimes called "pinpoint pupils," in someone difficult to awaken



    2. Family members, caregivers, or other people who may have to use NARCAN Nasal Spray in an opioid overdose should know where NARCAN Nasal Spray is stored and how to give NARCAN Nasal Spray before an opioid overdose happens.



    3. Get emergency medical help right away after giving the first dose of NARCAN Nasal Spray. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.



    4. The signs and symptoms of an opioid overdose can return after NARCAN Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new NARCAN Nasal Spray device and watch the person closely until emergency help is received.

    What should I tell my healthcare provider before using NARCAN Nasal Spray?

    Before using NARCAN Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you:

    • have heart problems



    • are pregnant or plan to become pregnant. Use of NARCAN Nasal Spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use NARCAN Nasal Spray.



    • are breastfeeding or plan to breastfeed. It is not known if NARCAN Nasal Spray passes into your breast milk.

    Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, drugs, vitamins, and herbal supplements.

    What are the possible side effects of NARCAN Nasal Spray?

    NARCAN Nasal Spray may cause serious side effects, including:

    Sudden opioid withdrawal symptoms which can be severe. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving NARCAN Nasal Spray and may include:

     •  body aches •  yawning
     •  diarrhea •  nausea or vomiting
     •  increased heart rate •  nervousness
     •  fever •  restlessness or irritability
     •  runny nose •  shivering or trembling
     •  sneezing •  stomach cramping
     •  goose bumps •  weakness
     •  sweating •  increased blood pressure

    Some patients may show aggressive behavior upon abrupt reversal of an opioid overdose.

    In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.

    These are not all of the possible side effects of NARCAN Nasal Spray. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

    NNS CON ISI 07/2020

    Please see full Prescribing Information.

    For additional information on NARCAN® Nasal Spray, please visit www.NARCAN.com.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

    Emergent BioSolutions®, NARCAN® and any and all Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. PP-NAR4-US-00362 Aug 2020 

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  12. GAITHERSBURG, Md., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) (the "Company") announced today that it has completed its previously announced offering of $450 million in aggregate principal amount of its 3.875% Senior Unsecured Notes due 2028 (the "Notes").

    The Notes are fully and unconditionally guaranteed on a senior unsecured basis by all of the Company's direct and indirect subsidiaries that guarantee debt under its credit facilities. The Company has used the net proceeds of the offering to repay the $353 million outstanding under its $600 million revolving credit facility with the remainder to be used for general corporate purposes.

    The Notes were offered in the United States to qualified institutional buyers…

    GAITHERSBURG, Md., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) (the "Company") announced today that it has completed its previously announced offering of $450 million in aggregate principal amount of its 3.875% Senior Unsecured Notes due 2028 (the "Notes").

    The Notes are fully and unconditionally guaranteed on a senior unsecured basis by all of the Company's direct and indirect subsidiaries that guarantee debt under its credit facilities. The Company has used the net proceeds of the offering to repay the $353 million outstanding under its $600 million revolving credit facility with the remainder to be used for general corporate purposes.

    The Notes were offered in the United States to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), and outside the United States pursuant to Regulation S under the Securities Act. The Notes were not registered under the Securities Act and may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws.

    This press release is neither an offer to sell nor the solicitation of an offer to buy the Notes or any other securities, and there shall not be any offer to sell, solicitation of an offer to buy or sale of the Notes in any jurisdiction in which, or to any person to whom, such an offer, solicitation or sale is unlawful. Any offers of the Notes will be made only by means of an offering memorandum.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030.

    Safe Harbor Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the intended use of proceeds, are forward-looking statements. We generally identify forward-looking statements by using words like "will," "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates" and similar expressions. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

    There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements. In addition, new factors that could cause actual results to differ from our expectations emerge from time to time and it is not possible for management to predict all such factors, nor can it assess the impact of any such factor on the business or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission when evaluating our forward-looking statements.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

    Primary Logo

    View Full Article Hide Full Article
  13. GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) (the "Company") announced today that it has priced its offering of $450 million aggregate principal amount of 3.875% Senior Unsecured Notes due 2028 (the "Notes"), representing an increase of $50 million in aggregate principal amount from the initially proposed offering size.

    The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by all of the Company's direct and indirect subsidiaries that guarantee debt under its credit facilities. The Company intends to use the net proceeds of the offering to repay the $353 million outstanding under its $600 million revolving credit facility with the remainder to be used for general corporate…

    GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) (the "Company") announced today that it has priced its offering of $450 million aggregate principal amount of 3.875% Senior Unsecured Notes due 2028 (the "Notes"), representing an increase of $50 million in aggregate principal amount from the initially proposed offering size.

    The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by all of the Company's direct and indirect subsidiaries that guarantee debt under its credit facilities. The Company intends to use the net proceeds of the offering to repay the $353 million outstanding under its $600 million revolving credit facility with the remainder to be used for general corporate purposes. The offering is expected to close on August 7, 2020, subject to customary closing conditions.

    The Notes are being offered in the United States to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), and outside the United States pursuant to Regulation S under the Securities Act.

    The Notes have not been registered under the Securities Act and may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. This notice is being issued pursuant to and in accordance with Rule 135c under the Securities Act.

    This press release is neither an offer to sell nor the solicitation of an offer to buy the Notes or any other securities, and there shall not be any offer to sell, solicitation of an offer to buy or sale of the Notes in any jurisdiction in which, or to any person to whom, such an offer, solicitation or sale is unlawful. Any offers of the Notes will be made only by means of an offering memorandum.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030.

    Safe Harbor Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the anticipated completion of the sale and issuance of the Notes and the intended use of proceeds, are forward-looking statements. We generally identify forward-looking statements by using words like "will," "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates" and similar expressions. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

    There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the uncertainties related to market conditions, the satisfaction of closing conditions and the completion of the sale and issuance of the Notes on the anticipated terms or at all. In addition, new factors that could cause actual results to differ from our expectations emerge from time to time and it is not possible for management to predict all such factors, nor can it assess the impact of any such factor on the business or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission when evaluating our forward-looking statements.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

     

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

     

    Primary Logo

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  14. GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) (the "Company") announced today that it intends to offer $400 million aggregate principal amount of senior unsecured notes with an expected maturity date of August 2028 (the "Notes"). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by all of the Company's direct and indirect subsidiaries that guarantee debt under its credit facilities. The Company intends to use the net proceeds of the offering to repay the $353 million outstanding under its $600 million revolving credit facility with the remainder to be used for general corporate purposes.

    The Notes will be offered in the United States to qualified institutional…

    GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) (the "Company") announced today that it intends to offer $400 million aggregate principal amount of senior unsecured notes with an expected maturity date of August 2028 (the "Notes"). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by all of the Company's direct and indirect subsidiaries that guarantee debt under its credit facilities. The Company intends to use the net proceeds of the offering to repay the $353 million outstanding under its $600 million revolving credit facility with the remainder to be used for general corporate purposes.

    The Notes will be offered in the United States to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), and outside the United States pursuant to Regulation S under the Securities Act. The Notes have not been registered under the Securities Act and may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. This notice is being issued pursuant to and in accordance with Rule 135c under the Securities Act.

    This press release is neither an offer to sell nor the solicitation of an offer to buy the Notes or any other securities, and there shall not be any offer to sell, solicitation of an offer to buy or sale of Notes in any jurisdiction in which, or to any person to whom, such an offer, solicitation or sale is unlawful. Any offers of the Notes will be made only by means of an offering memorandum.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030.

    Safe Harbor Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the anticipated completion of the sale and issuance of the Notes and the intended use of proceeds, are forward-looking statements. We generally identify forward-looking statements by using words like "will," "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates" and similar expressions. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

    There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the uncertainties related to market conditions, the satisfaction of closing conditions and the completion of the sale and issuance of the Notes on the anticipated terms or at all. In addition, new factors that could cause actual results to differ from our expectations emerge from time to time and it is not possible for management to predict all such factors, nor can it assess the impact of any such factor on the business or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission when evaluating our forward-looking statements.

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392

    Primary Logo

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    • Establishes key collaborations with industry, U.S. government, and health care providers to help advance COVID-19 vaccine and therapeutic solutions
    • Current quarter and year-to-date performance reflect strength of core medical countermeasure business and increased impact of CDMO business

    GAITHERSBURG, Md., July 30, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today reported financial results for the three and six months ended June 30, 2020 and revised upward full year 2020 guidance.

    "While we mobilize to meet the threat presented by COVID-19, we are also successfully delivering on our long-term strategy," said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. "Our decades of experience…

    • Establishes key collaborations with industry, U.S. government, and health care providers to help advance COVID-19 vaccine and therapeutic solutions

    • Current quarter and year-to-date performance reflect strength of core medical countermeasure business and increased impact of CDMO business

    GAITHERSBURG, Md., July 30, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today reported financial results for the three and six months ended June 30, 2020 and revised upward full year 2020 guidance.

    "While we mobilize to meet the threat presented by COVID-19, we are also successfully delivering on our long-term strategy," said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. "Our decades of experience in addressing public health threats have prepared us to do both these things well, ensuring that we are staying true to our mission to protect and enhance life."

    FINANCIAL HIGHLIGHTS (unaudited)

    (in millions)Q2 2020Q2 2019$ Change% Change
    Total Revenues$394.7$243.2

    $151.562.3%
    Net Income (Loss)$92.7$(9.5)$102.2*
    Adjusted Net Income (1)$105.7$10.2

    $95.5*
    Adjusted EBITDA (1)$156.1$29.4

    $126.7431.0%



    (in millions)YTD 2020YTD 2019$ Change% Change
    Total Revenues$587.2$433.9

    $153.335.3%
    Net Income (Loss)$80.2$(35.6)$115.8325.3%
    Adjusted Net Income (1)$106.0$4.8

    $101.2*
    Adjusted EBITDA (1)$171.4$37.6

    $133.8355.9%
    * % change is greater than 500%

    Q2 2020 AND OTHER RECENT BUSINESS ACCOMPLISHMENTS

    • Awarded landmark public-private contract development and manufacturing (CDMO) partnership task order by the U.S. Department of Health and Human Services (HHS) under Operation Warp Speed valued at approximately $628 million for production of leading pharmaceutical and biotechnology innovators' COVID-19 vaccine candidates through 2021 and viral drug product capacity expansion at the Company's Rockville, Maryland facility

       
    • Signed five-year large-scale drug substance manufacturing agreement for Johnson & Johnson's lead COVID-19 vaccine candidate beginning in 2021, valued at approximately $480 million for the first two years; follows initial agreement, valued at approximately $135 million, to provide CDMO services and secure large-scale manufacturing capacity

       
    • Signed three-year large-scale drug substance manufacturing agreement for AstraZeneca's COVID-19 vaccine candidate, valued at approximately $174 million through 2021; follows initial agreement, valued at approximately $87 million, to provide CDMO services and secure large-scale manufacturing capacity
    • Awarded $34.6 million by the U.S. Department of Defense Joint Program Executive Office and formed collaboration with Mount Sinai Health System and ImmunoTek Bio Centers to advance the Company's COVID- Human Immune Globulin (COVID-HIG) therapeutic candidate for potential post-exposure prophylaxis in populations at high risk of COVID-19

       
    • Announced contract option valued at $258 million exercised by HHS to continue to procure AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) for delivery into the U.S. Strategic National Stockpile (SNS) over 12 months

       
    • Announced contract option valued at $176 million exercised by HHS to continue to procure ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) for delivery into the SNS over 12 months

       
    • Executed contract option valued at $54 million exercised by HHS to continue to procure VIGIV [Vaccinia Immune Globulin Intravenous (Human)] for delivery into the SNS over 12 months

       
    • Announced a $75 million CDMO investment in the Company's Canton, Massachusetts facility and drug substance expansion into viral vector and gene therapy, expected to be available in Q2 2023

    2020 FINANCIAL PERFORMANCE (unaudited)

    (I) Quarter Ended June 30, 2020 (Q2)

    Revenues

    Total Revenues

    For Q2 2020, total revenues were $394.7 million, an increase of $151.5 million over 2019. Total revenues reflect an increase in product sales and contract development and manufacturing services revenues partially offset by a decrease in contracts and grants revenues.

    Product Sales

    For Q2 2020, product sales were $298.5 million, an increase of $115.0 million or 63% as compared to 2019. The change primarily reflects increased sales of anthrax vaccines and ACAM2000 offset by a decrease in Other, specifically sales of raxibacumab and travel health vaccines.





    (in millions)
    Three Months Ended June 30,
    2020

    2019% Change
    Product Sales
    NARCAN Nasal Spray$72.8$73.0—%
    ACAM2000$70.0$6.5NM
    Anthrax vaccines$132.3$28.0NM
    Other$23.4$76.0(69)%
    Total Product Sales$298.5$183.563%

    Contract Development and Manufacturing Services (CDMO)

    For Q2 2020, revenue from the Company's contract development and manufacturing operations was $72.6 million, an increase of $53.9 million as compared to 2019. The increase is largely due to the contribution of recently announced arrangements across development services, drug substance, and drug product with industry and government, most notably the Company's landmark public-private CDMO partnership with BARDA in support of the U.S. government's Operation Warp Speed Program.

    Contracts and Grants

    For Q2 2020, revenue from the Company's development-based contracts and grants was $23.6 million, a decrease of

    $17.4 million as compared to 2019. The decrease primarily reflects the completion of development activities associated with the AV7909 product candidate in 2019, partially offset by recent new development awards related to the COVID-HIG product candidate during the current quarter.

    Operating Expenses

    Cost of Product Sales and Contract Development and Manufacturing Services

    For Q2 2020, cost of product sales and contract development and manufacturing services was $129.8 million, an increase of $29.0 million or 29% as compared to 2019. The increase is primarily due to the increase in volume of product sales and CDMO services and an increase in share-based compensation expense due to a special broad-based, immediately vested equity award to employees.

    Research and Development (Gross and Net)

    For Q2 2020, gross R&D expenses were $47.9 million, a decrease of $16.0 million or 25% as compared to 2019. The decrease primarily reflects a decline in costs associated with the Company's AV7909 product candidate and FLU-IGIV product candidate partially offset by an increase in costs associated with the Company's chikungunya product candidate. During 2019, the Company completed its development activities for AV7909.

    For Q2 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $24.3 million, a decrease of $1.4 million or 6% as compared to 2019. The decrease is attributable to a decline in costs associated with the Company's FLU-IGIV product candidate partially offset by an increase in costs associated with the Company's chikungunya product candidate. The Q2 2020 and Q2 2019 net R&D expense was 7% and 11%, respectively, of adjusted revenue (total revenue less contracts & grants).





    (in millions)
    Three Months Ended June 30,
    20202019% Change
    Research and Development Expenses$47.9$63.9(25)%
    Adjustments:
    Less Contracts and Grants Revenue$23.6$41.0(42)%
    Net Research and Development Expenses$24.3$22.96%
    Adjusted Revenue

    (Total Revenue less Contracts and Grants Revenue)
    $371.1$202.284%
    Net R&D as % of Adjusted Revenue (Net R&D Margin)7%11%NA

    Selling, General and Administrative

    For Q2 2020, selling, general and administrative expenses were $76.0 million, an increase of $5.2 million or 7% as compared to 2019. The increase primarily reflects an increase in share-based compensation due to a special broad-based, immediately vested equity award to employees as well as staffing costs to support the Company's growth.

    Amortization of Intangible Assets

    For Q2 2020, amortization of intangible assets was $15.0 million, which was consistent with amortization of intangible assets of $14.7 million in Q2 2019.

    Income Taxes

    For Q2 2020, the income tax provision in the amount of $28.0 million increased due to the Company being in a net income position as compared to a net loss position during Q2 2019.

    Net Income (Loss) & Adjusted Net Income

    For Q2 2020, the Company recorded net income of $92.7 million, or $1.73 per diluted share, versus a net loss of $9.5 million, or $(0.18) per diluted share, in 2019.

    For Q2 2020, the Company recorded adjusted net income of $105.7 million, or $1.98 per diluted share, versus an adjusted net income of $10.2 million, or $0.20 per diluted share, in 2019. (1)

    Adjusted EBITDA

    For Q2 2020, the Company recorded adjusted EBITDA of $156.1 million versus $29.4 million in 2019. (1)

    (II) Six months ended June 30, 2020 (unaudited)

    Revenues

    Total Revenues

    For the six months ended June 30, 2020, total revenues were $587.2 million, an increase of 35% over 2019. Total revenues reflect an increase in product sales and contract development and manufacturing services offset by a decline in contracts and grants.

    Product Sales

    For the six months ended June 30, 2020, product sales were $446.7 million, an increase of $110.2 million or 33% as compared to 2019. The increase primarily reflects sales of anthrax vaccines, offset by decreased sales of raxibacumab and travel health vaccines reflected in Other below.





    (in millions)
    Six Months Ended June 30,
    2020

    2019% Change
    Product Sales
    NARCAN Nasal Spray$145.0$138.55%
    ACAM2000$70.0$52.035%
    Anthrax vaccines$184.2$39.6NM
    Other$47.5$106.4(55)%
    Total Product Sales$446.7$336.533%

    Contract Development and Manufacturing Services (CDMO)

    For the six months ended June 30, 2020, revenue from the Company's contract development and manufacturing services operations was $94.3 million, an increase of $59.7 million or 173% as compared to 2019. The increase is largely due to the contribution of recently announced arrangements across development services, drug substance and drug product with industry and government, specifically our landmark public-private CDMO partnership with BARDA in support of the U.S. government's Operation Warp Speed Program.

    Contracts and Grants

    For the six months ended June 30, 2020, revenue from the Company's development-based contracts and grants was $46.2 million, a decrease of $16.6 million or 26% as compared to 2019. The decrease primarily reflects the completion of development activities associated with the AV7909 product candidate in 2019, offset by recent new development awards related to the Company's COVID-HIG product candidate.

    Operating Expenses

    Cost of Product Sales and Contract Development and Manufacturing Services

    For the six months ended June 30, 2020, cost of product sales and contract development and manufacturing services was $206.7 million, an increase of $14.0 million or 7% as compared to 2019. The increase is primarily due to the increase in volume of product sales and CDMO services and an increase in share-based compensation expense due to a special broad-based, immediately vested equity award to employees.

    Research and Development (Gross and Net)

    For the six months ended June 30, 2020, gross R&D expenses were $90.6 million, a decrease of $19.4 million compared to 2019. The decrease primarily reflects a decline in costs associated with the Company's AV7909 product candidate and FLU-IGIV product candidate as the Company was incurring costs associated with phase 2 clinical trials for FLU-IGIV partially offset by an increase in costs associated with the Company's chikungunya product candidate.

    For the six months ended June 30, 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $44.4 million, a decrease of $2.8 million or 6% as compared to 2019. The decrease primarily reflects a decline in costs associated with the FLU-IGIV product candidate as the Company was incurring costs associated with phase 2 clinical trials in 2019 partially offset by an increase in costs associated with the Company's chikungunya product candidate. The 2020 and 2019 net R&D expense was 8% and 13%, respectively, of adjusted revenue (total revenue less contracts & grants).





    (in millions)
    Six Months Ended June 30,
    2020

    2019

    % Change
    Research and Development Expenses$90.6

    $110.0

    -18%
    Adjustments:
    Less Contracts and Grants Revenue$46.2

    $62.8

    (26)%
    Net Research and Development Expenses$44.4

    $47.2

    (6)%
    Adjusted Revenue

    (Total Revenue less Contracts and Grants Revenue)
    $541.0

    $371.1

    46%
    Net R&D as % of Adjusted Revenue (Net R&D Margin)8%13%NA

    Selling, General and Administrative

    For the six months ended June 30, 2020, selling, general and administrative expenses were $145.7 million, an increase of $9.3 million or 7% as compared to 2019. The increase primarily reflects an increase in share-based compensation due to a special broad-based, immediately vested equity award to employees as well as staffing costs to support the Company's growth.

    Amortization of Intangible Assets

    For the six months ended June 30, 2020, amortization of intangible assets of $29.8 million was consistent with $29.2 million in 2019.

    Income Taxes

    For the six months ended June 30, 2020, the income tax provision of $19.2 million increased due to the Company being in a net income position as compared to a net loss position during the six months ended June 30, 2019.

    Net Income (Loss) & Adjusted Net Income

    For the six months ended June 30, 2020, the Company recorded net income of $80.2 million, or $1.51 per diluted share, versus a net loss of $35.6 million, or $(0.69) per diluted share, in 2019.

    For the six months ended June 30, 2020, the Company recorded adjusted net income of $106.0 million, or $1.99 per diluted share, versus adjusted net income of $4.8 million, or $0.09 per diluted share, in 2019. (1)

    Adjusted EBITDA

    For the six months ended June 30, 2020, the Company recorded adjusted EBITDA of $171.4 million versus $37.6 million in 2019. (1)

    2020 FINANCIAL FORECAST

    Based upon the Company's financial performance year to date as well as expectations for the remainder of the year, the Company has revised its full year 2020 financial forecast reflected by the following financial metrics and accompanying operational considerations:

    Financial Metrics

     



    (in millions)
    REVISED 2020 FORECAST

    (As of 7/30/2020)
    previous 2020 forecast

    (As of 4/30/2020)
    Total Revenues$1,500 - $1,600$1,175 -- $1,275
    • NARCAN Nasal Spray$285 - $315$285 - $315
    • Anthrax vaccines$320 - $350$270 - $300
    • ACAM2000$180 - $200$180 - $200
    • Contract development and manufacturing services$440 - $460$125 - $145
    Adjusted Net Income (1)$340 - $390$160 -- $210
    Adjusted EBITDA (1)$535 - $600$300 -- $360

    Operational Considerations

    • Year over year improvement in gross margin of 400 - 600 basis points (previous range 200 - 400 basis points) driven by improved product mix and increased contribution from our CDMO business;
    • The delay into 2021 of the launch of the Phase 3 clinical study for CHIKV-VLP, the Company's chikungunya virus virus-like particle vaccine, due to the timing of certain operational factors;
    • The deferral into 2021 of a follow-on procurement contract with the U.S. government for raxibacumab, the Company's Food and Drug Administration-approved anthrax monoclonal antibody therapeutic, due to the impact of the prioritization of Operation Warp Speed on the Company's technology transfer activities for the product;
    • Continued challenges through the end of 2020 in the Company's travel health business and revenues associated with Vaxchora®(Cholera Vaccine, Live, Oral) and Vivotif®(Typhoid Vaccine Live Oral Ty21a)
    • No generic competition in 2020 for NARCAN®(naloxone HCl) Nasal Spray.

    Emergent has assessed the risks to its business associated with the COVID-19 pandemic and has adopted measures to mitigate those risks as they are understood today and accordingly is providing this outlook for 2020. Despite the lack of expected material disruption to the company's business, the management team continues to assess the business and operational implications associated with the pandemic and market conditions on its employees, patients and customers.

    The outlook for 2020 does not include estimates for potential new corporate development or other M&A transactions.

    Q3 2020 REVENUE FORECAST

    For Q3 2020, the Company forecast for total revenues is $420 million - $450 million.

    FOOTNOTES

    (1) See "Reconciliation of Net Income (Loss) to Adjusted Net Income and Adjusted EBITDA" for a definition of terms and the reconciliation tables.

    CONFERENCE CALL, PRESENTATION SUPPLEMENT, AND WEBCAST INFORMATION

    Company management will host a conference call at 5:00 pm (Eastern Time) today, July 30, 2020, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company's website or through the following:

    Live Teleconference Information:

    Dial in: [US] (855) 766-6521; [International] (262) 912-6157

    Conference ID: 7380905

    Live Webcast Information:

    Visit https://edge.media-server.com/mmc/p/bkkqx6kk for the live webcast feed.

    A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."

    ABOUT EMERGENT BIOSOLUTIONS INC.

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information

    visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

    SAFE HARBOR STATEMENT

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, our financial guidance and related projections and statements regarding our ability to meet such projections in the anticipated timeframe, if at all; statements regarding the success of our measures to mitigate the impact on our business and operations of the novel strain of coronavirus (SARS-CoV-2) causing COVID-19 disease; total contract value; annual improvement in gross margin driven by improved product and services mix and sales of certain key components of the product portfolio at specified levels; the lack of generic competition for NARCAN®(naloxone HCl) Nasal Spray for the remainder of 2020; our ability to develop safe and effective treatments for COVID-19 and obtain FDA approval or authorization for emergency or broader patient use of such treatments; the entry into a follow-on procurement contract for raxibacumab in 2021; the launch of the Phase 3 clinical study for CHIKV-VLP; the impact on our revenues from declines in sales of our vaccine products that target travelers due to the reduction of international travel caused by the COVID-19 pandemic and any other statements containing the words "will," "believes," "expects," "anticipates," "intends," "plans," "targets," "forecasts," "estimates" and similar expressions in conjunction with, among other things, discussions of the Company's outlook, financial performance or financial condition, financial and operation goals, strategic goals, growth strategy, product sales, government development or procurement contracts or awards, government appropriations, manufacturing capabilities, and the timing of certain regulatory approvals or expenditures are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate.

    Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statements speak only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the impact of global economic conditions and public health crises and epidemics, such as the impact from the global pandemic that arose from the novel strain of coronavirus (SARS-CoV-2) causing COVID-19 disease, on the markets, our operations, and employees as well as those of our customers and suppliers; availability of U.S. government funding for procurement for our products; our ability to perform under our contracts with the U.S. government, including the timing of and specifications relating to deliveries; the continued exercise of discretion by BARDA to procure additional doses of AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) prior to approval by the FDA; our ability to secure licensure of AV7909 from the FDA within the anticipated timeframe, if at all; our ability to secure follow-on procurement contracts for our solutions to public health threats that are under procurement contracts that have expired or will be expiring; our ability to successfully appeal the recent patent litigation decision related to NARCAN®(naloxone hydrochloride) Nasal Spray 4mg/spray; our ability and the ability of our collaborators to enforce patents related to NARCAN Nasal Spray against potential generic entrants; our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria; our ability and the ability of our contractors and suppliers to maintain compliance with Current Good Manufacturing Practices and other regulatory obligations; our ability to comply with the operating and financial covenants required by our senior secured credit facilities; our ability to obtain and maintain regulatory approvals for our product candidates and the timing of any such approvals; the safety and effectiveness of the current COVID-19 product candidates we are working on; the procurement of products by U.S. government entities under regulatory exemptions prior to approval by the FDA and corresponding procurement by government entities outside of the United States under regulatory exemptions prior to approval by the corresponding regulatory authorities in the applicable country; the success of our commercialization, marketing and manufacturing capabilities and strategy; and the accuracy of our estimates regarding future revenues, expenses, and capital requirements and needs for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission when evaluating our forward-looking statements.

    Investor ContactMedia Contact
    Robert BurrowsMiko B. Neri
    Vice President, Investor RelationsSenior Director, Global Communications & Public Affairs
    (o) 240/631-3280; (m) 240/413-1917(o) 240/631-3392
     



    Emergent BioSolutions Inc.

    Consolidated Statements of Operations

    (unaudited, in millions, except per share data)





    ASSETS
     June 30, 2020  December 31, 2019 
    Current assets:      
    Cash and cash equivalents$268.8 $167.8 
    Restricted cash 0.2  0.2 
    Accounts receivable, net 258.6  270.7 
    Inventories 236.2  222.5 
    Prepaid expenses and other current assets 32.1  25.0 
    Total current assets 795.9  686.2 




    Property, plant and equipment, net
     



    580.1
      



    542.3
     
    Intangible assets, net 693.2  712.9 
    In-process research and development 29.0  29.0 
    Goodwill 266.3  266.6 
    Other assets 101.6  90.3 
    Total assets$2,466.1 $2,327.3 

    LIABILITIES AND STOCKHOLDERS' EQUITY

    Current liabilities:

    Accounts payable$84.8 $94.8 
    Accrued expenses 33.8  39.5 
    Accrued compensation 59.0  62.4 
    Debt, current portion 29.1  12.9 
    Contract liabilities, current portion 32.7  3.3 
    Contingent consideration, current portion 22.3  3.2 
    Other current liabilities 32.0  0.2 
    Total current liabilities 293.7  216.3 
    Contingent consideration, net of current portion 6.9  26.0 
    Debt, net of current portion 758.1  798.4 
    Deferred tax liability 63.9  63.9 
    Contract liabilities, net of current portion 85.3  85.6 
    Other liabilities 59.4  48.6 
    Total liabilities$1,267.3 $1,238.8 




    Stockholders' equity:
          



    Preferred stock, $0.001 par value; 15.0 shares authorized, no shares issued or

    outstanding 
        
    Common stock, $0.001 par value; 200.0 shares authorized, 54.1 and 53.0 shares issued; 52.9 and 51.7 shares outstanding, respectively 0.1  0.1 
    Treasury stock, at cost, 1.2 common shares (39.6) (39.6)
    Additional paid-in capital 758.5  716.1 
    Accumulated other comprehensive loss, net (22.2) (9.9)
    Retained earnings 502.0  421.8 
    Total stockholders' equity 1,198.8  1,088.5 
    Total liabilities and stockholders' equity$2,466.1 $2,327.3 

                  

    Emergent BioSolutions Inc.

    Consolidated Statements of Operations

    (unaudited, in millions, except per share data)

     Three Months Ended June 30,Six Months Ended June 30,
     2020201920202019




    Revenues:
         
    Product sales, net$298.5 183.5 446.7 336.5 
    Contract development and manufacturing     
    services72.6 18.7 94.3 34.6 
    Contracts and grants23.6 41.0 46.2 62.8 
    Total revenues394.7 243.2 587.2 433.9 
    Operating expenses:    
    Cost of product sales and contract development and manufacturing services



    129.8
     



    100.8
     



    206.7
     



    192.7
     
    Research and development47.9 63.9 90.6 110.0 
    Selling, general and administrative76.0 70.8 145.7 136.4 
    Amortization of intangible assets15.0 14.7 29.8 29.2 
    Total operating expenses268.7 250.2 472.8 468.3 
    Income (loss) from operations126.0 (7.0)114.4 (34.4)
    Other income (expense):    
    Interest expense(6.4)(9.5)(15.0)(19.0)
    Other, net1.1 1.4 0.0 0.4 
    Total other income (expense), net(5.3)(8.1)(15.0)(18.6)




    Income (loss) before provision for income
           
    taxes 120.7 (15.1)99.4 (53.0)
    Income tax provision (benefit) 28.0 (5.6)19.2 (17.4)
    Net income (loss)$92.7 (9.5)80.2 (35.6)




    Net income (loss) per common share
         
    Basic$1.76 (0.18)1.53 (0.69)
    Diluted$1.73 (0.18)1.51 (0.69)



    Shares used in computing income (loss) per share    
    Basic52.651.552.351.3
    Diluted53.551.553.251.3



    Emergent BioSolutions Inc.

    Condensed Consolidated Statements of Cash Flows

    (unaudited, in millions)

      
     Six Months Ended June 30,
     June 30, 2020June 30, 2019
    Cash flows provided by operating activities:  
    Net income (loss)$80.2 $(35.6)
    Adjustments to reconcile net income (loss) to net cash provided by operating activities:      
    Stock-based compensation expense 31.0  14.9 
    Depreciation and amortization 56.8  55.1 
    Amortization of deferred financing costs 1.5  1.5 
    Deferred income taxes (3.7) (1.3)
    Change in fair value of contingent consideration, net 1.1  5.5 
    Other 1.1  2.9 
    Changes in operating assets and liabilities:  
    Accounts receivable 12.1  44.6 
    Inventories (13.7) (26.1)
    Prepaid expenses and other assets (16.9) (44.9)
    Accounts payable (14.5) 42.6 
    Accrued expenses 25.0  6.9 
    Accrued compensation (3.4) (13.5)
    Contract liabilities 29.1  16.4 
    Net cash provided by operating activities: 185.7  69.0 
    Cash flows used in investing activities:

     
    Purchases of property, plant and equipment and other (59.3) (35.5)
    Milestone payment from prior asset acquisition (10.0) (10.0)
    Net cash used in investing activities: (69.3) (45.5)
    Cash flows (used in) provided by financing activities:



    Proceeds from revolving credit facility   130.0 
    Principal payments on revolving credit facility (20.0) (80.0)
    Principal payments on term loan facility (5.6) (5.6)
    Proceeds from exercise of stock options 23.1  4.6 
    Taxes paid for share-based compensation activity (11.7) (6.3)
    Contingent consideration payments (1.1) (1.0)
    Net cash (used in) provided by financing activities: (15.3) 41.7 
    Effect of exchange rate changes on cash, cash equivalents and restricted cash (0.1)  
    Net increase in cash, cash equivalents and restricted cash 101.0  65.2 
    Cash, cash equivalents and restricted cash at beginning of period 168.0  112.4 
    Cash, cash equivalents and restricted cash at end of period$269.0 $177.6 



    RECONCILIATION OF NET INCOME (LOSS) TO ADJUSTED NET INCOME AND ADJUSTED EBITDA (unaudited)

    This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Depreciation and Amortization, Interest and Taxes)) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company's definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted net income (loss) adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges resulting from purchase accounting. All adjustments are tax effected utilizing the federal statutory tax rate for the US, except for changes in the fair value of contingent consideration as the vast majority is non-deductible for tax purposes. Adjusted net income (loss) margin is defined as adjusted net income (loss) divided by total revenues. Adjusted EBITDA reflects net income (loss) excluding the impact of depreciation, amortization, interest expense and provision (benefit) for (from) income taxes, excluding specified items that can be highly variable and the non-cash impact of certain purchase accounting adjustments. Adjusted EBITDA margin is defined as Adjusted EBITDA divided by total revenues. The Company views these non-GAAP financial measures as a means to facilitate management's financial and operational decision-making, including evaluation of the Company's historical operating results and comparison to competitors' operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company's operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure may provide a more complete understanding of factors and trends affecting the Company's business.

    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. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety.

    Reconciliation of Net Income (Loss) to Adjusted Net Income (Unaudited)

     



    (in millions, except per share value)
    Three Months Ended June 30,
    20202019Source
    Net income (loss)$92.7

    ($9.5) 
    Adjustments:
    + Acquisition-related costs (transaction & integration)

    3.5

    SG&A
    + Non-cash amortization charges15.8

    15.4

    SG&A, Other Income
    + Changes in fair value of contingent consideration0.5

    3.9

    SG&A
    + Impact of purchase accounting on inventory step-up

    1.1

    COGS
    Tax effect(3.3)(4.2) 
    Total adjustments:13.0

    19.7

     
     Adjusted net income$ 105.7

    $ 10.2

     
    Adjusted net income per diluted share$1.98

    $0.20

     



     



    (in millions, except per share value)
    Six Months Ended June 30,
     2020  2019 Source
    Net income (loss)$80.2 ($35.6) 
    Adjustments:
    + Acquisition-related costs (transaction & integration) —  7.4 SG&A
    + Non-cash amortization charges 31.3  30.7 SG&A, Other Income
    + Changes in fair value of contingent consideration 1.1  5.5 COGS
    + Impact of purchase accounting on inventory step-up —  6.1 COGS
    Tax effect (6.6) (9.3) 
    Total adjustments: 25.8  40.4  
    Adjusted net income$106.0 $4.8  
    Adjusted net income per diluted share$1.99 $0.09  



     



    (in millions)
    REVISED 2020 Full Year Forecast
    2020FSource
    Net income$290 - $340 
    Adjustments:
    + Non-cash amortization charges 62Intangible Asset Amortization, Other Income
    + Change in fair value of contingent consideration2COGS
    Tax effect(14) 
    Total adjustments:50 
    Adjusted net income$340 - $390 



    Reconciliation of Net Income (Loss) to Adjusted EBITDA (Unaudited)

     



    (in millions)
    Three Months Ended June 30,
     20202019 
    Net income (loss)$92.7($9.5)
    Adjustments:
    + Depreciation & amortization 28.627.2 
    + Provision (benefit) for (from) income taxes 28.0(5.6)
    + Total interest expense, net* 6.38.8 
    + Changes in fair value of contingent consideration 0.53.9 
    + Acquisition-related costs (transaction & integration) —3.5 
    + Impact of purchase accounting on inventory step-up —1.1 
    Total adjustments 63.438.9 
    Adjusted EBITDA$156.1$29.4 
    * Includes interest income of $0.1 million in 2020 and $0.6 million in 2019



     



    (in millions)
    Six Months Ended June 30,
     2020 2019 
    Net income (loss)$80.2($35.6)
    Adjustments:
    + Depreciation & amortization56.853.8
    + Provision (benefit) for (from) income taxes19.2(17.4)
    + Total interest expense, net*14.117.8
    + Changes in fair value of contingent consideration1.15.5
    + Acquisition-related costs (transaction & integration)7.4
    + Impact of purchase accounting on inventory step-up6.1
    Total additional adjustments91.273.2
    Adjusted EBITDA$171.4$37.6
    * Includes interest income of $0.9 million in 2020 and $1.2 million in 2019



     



    (in millions)
    REVISED 2020 Full Year Forecast
    2020F
    Net income$290 - $340
    Adjustments:
    + Depreciation & amortization115
    + Provision for income taxes98 to 113
    + Total interest expense30
    + Change in fair value of contingent consideration2
    Total additional adjustments245 to 260
    Adjusted EBITDA$535 - $600

     

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    • Emergent will provide contract development and manufacturing services beginning in 2020 to produce drug substance at large scale for commercial supply
    • Agreement is valued at approximately $174 million through 2021 and brings the total AstraZeneca commitment to $261 million
    • Parties may enter into additional commercial manufacturing commitments as the candidate progresses over three years through Emergent's flexible capacity deployment model

    GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca's COVID-19 vaccine candidate, AZD1222…

    • Emergent will provide contract development and manufacturing services beginning in 2020 to produce drug substance at large scale for commercial supply
    • Agreement is valued at approximately $174 million through 2021 and brings the total AstraZeneca commitment to $261 million
    • Parties may enter into additional commercial manufacturing commitments as the candidate progresses over three years through Emergent's flexible capacity deployment model

    GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca's COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.

    "Emergent is driven by our desire to advance solutions that will make an impact on this pandemic," said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. "Sharing a passion for science, we are encouraged by AstraZeneca's investigational COVID-19 vaccine and look forward to supporting its continued progress."

    The adenovirus vector-based vaccine candidate, AZD1222, was co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed by AstraZeneca. The vaccine candidate is currently in clinical trials. It is one of the candidates funded and supported by Operation Warp Speed (OWS), the U.S. government's program to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures that aims to have substantial quantities of a safe and effective vaccine available.

    Syed T. Husain, senior vice president and CDMO business unit head at Emergent, stated, "As COVID-19 vaccine candidates progress through the pipeline, Emergent stands ready alongside leading innovators to rapidly deploy our CDMO services to help meet the substantial demand for a vaccine – anchored on our foundational expertise in development and manufacturing and propelled by our commitment to our mission – to protect and enhance life."

    This agreement follows and is in addition to the landmark public-private CDMO partnership between Emergent and the Biomedical Advanced Research and Development Authority (BARDA) announced in June to pave the way for OWS high-priority innovators.

    Activities under this agreement will be performed at Emergent's Baltimore Bayview facility, where certain manufacturing capacity reserved by BARDA through the CDMO task order issued to Emergent under OWS will be used. Emergent's Baltimore Bayview facility is a designated Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS) designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies.

    The CIADM has unique capabilities across four independent suites to produce at clinical scale to get candidates rapidly into the clinic, while at the same time scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes to meet customer demand. The CIADM has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used.

    Financial Considerations

    The company will provide an update to its 2020 financial outlook incorporating expectations related to this agreement and any other relevant information when it reports its second quarter financial results on July 30, 2020.

    About Emergent BioSolutions

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what's most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

    Emergent's Response to COVID-19

    Emergent BioSolutions is deploying its decades of experience in vaccine and hyperimmune development and manufacturing, as well as its molecule-to-market contract development and manufacturing (CDMO) services to provide comprehensive medical countermeasure solutions in response to the COVID-19 pandemic.

    Using its established hyperimmune platforms, Emergent is developing two investigational plasma-based treatments - COVID-Human Immune Globulin (COVID-HIG) and COVID-Equine Immune Globulin (COVID-EIG). COVID-HIG is being developed as a human plasma-derived therapy candidate with $14.5 million in HHS funding and will be evaluated in two studies of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for potential treatment of COVID-19 in severe hospitalized and high-risk patients. With $34.6 million in funding from the Department of Defense and in collaboration with the Mount Sinai Health System and ImmunoTek Bio Centers, COVID-HIG will also be evaluated for post-exposure prophylaxis in populations at high risk of COVID-19, such as front-line health care workers and the military. COVID-EIG is being developed as an equine plasma-derived therapy candidate for potential treatment of severe disease in humans. Both candidates are anticipated to be in Phase 2 clinical studies in 2020. These investigational products are not approved by the U.S. Food and Drug Administration and their safety and effectiveness have not been established.

    Emergent is deploying its CDMO capabilities, capacities, and expertise to support the U.S. government's Operation Warp Speed to pave the way for innovators to advance COVID-19 programs. The company is working with four innovators to develop and manufacture COVID-19 vaccine candidates. For the COVID-19 vaccine response, Emergent's integrated CDMO network provides development services from its Gaithersburg facility, drug substance manufacturing at its Baltimore Bayview facility, and drug product manufacturing at its Baltimore Camden and Rockville facilities, all in Maryland.

    For 22 years Emergent has focused on advancing public health, and its multi-pronged approach to tackling COVID-19 demonstrates its commitment to its mission – to protect and enhance life. 

    Safe Harbor Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to produce viable COVID-19 vaccine candidates at the prescribed scale and on the anticipated timeline and pave their potential pathway to licensure, the total value and anticipated duration of activities under the announced AstraZeneca contract as well as the negotiation of any further commitments or contracts related to the collaboration and deployment of capacity toward future commercial manufacturing, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

    There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for the product candidates; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

    Media Contact:

    Miko B. Neri

    Senior Director, Global Communications & Public Affairs

    240-631-3392



    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280



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  15. GAITHERSBURG, Md., July 21, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that Standard & Poor's (S&P) has indicated that the company will be added to the S&P MidCap 400® index, effective prior to the open of trading on Friday, July 24. The company will be classified under S&P's Global Industry Classification Standard (GICS) Biotechnology Sub-Industry index.

    "The addition of Emergent to the S&P MidCap 400 is an important milestone as we continue on our growth trajectory," said Richard S. Lindahl, executive vice president and chief financial officer of Emergent BioSolutions. "This move reflects our strong progress as a global life sciences company committed to addressing public health threats, and our effort