EBS Emergent Biosolutions Inc.

62.04
-1.34  -2%
Previous Close 63.38
Open 62.64
52 Week Low 55.0692
52 Week High 137.61
Market Cap $3,331,593,227
Shares 53,700,729
Float 43,295,920
Enterprise Value $3,828,310,451
Volume 397,890
Av. Daily Volume 655,322
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Drug Pipeline

Drug Stage Notes
CHIKV-VLP
Chikungunya virus
Phase 2
Phase 2
Phase 3 trial to be initiated in 2021.
COVID-EIG
COVID-19
Phase 2
Phase 2
Phase 2 trial planned.
COVID-HIG
COVID-19
Phase 3
Phase 3
Phase 3 initiation announced October 8, 2020.
FLU-IGIV
Influenza A
Phase 2
Phase 2
Phase 3 trial to commence in 2020.
VLA1601
Zika vaccine
Phase 1
Phase 1
Phase 1 data released November 19, 2018 - primary endpoint met with favorable safety profile.
BioThrax
Anthrax Vaccine Adsorbed
Approved
Approved
Approved November 24, 2015.
Anthrax Immune Globulin Intravenous (Human) [AIGIV]
Anthrax
Approved
Approved
Approved March 25, 2015.
BioThrax
Anthrax Vaccine
Approved
Approved
Approved May 17, 2012.

Latest News

    • Reaffirms 2021 Full Year Forecast for Revenues and Profit

    GAITHERSBURG, Md., July 29, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today reported financial results for the second quarter ended June 30, 2021.

    "Our second quarter performance demonstrates the strength of our strategy and diversified business model," said Robert G. Kramer, president and chief executive officer of Emergent BioSolutions. "Through continued investment and innovation, we will play an important role in helping deliver solutions to the public health threats we face. We are proud to be resuming production of COVID-19 vaccine batches following additional reviews and collaboration with the Food and Drug Administration and our manufacturing partner."

    • Reaffirms 2021 Full Year Forecast for Revenues and Profit

    GAITHERSBURG, Md., July 29, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today reported financial results for the second quarter ended June 30, 2021.

    "Our second quarter performance demonstrates the strength of our strategy and diversified business model," said Robert G. Kramer, president and chief executive officer of Emergent BioSolutions. "Through continued investment and innovation, we will play an important role in helping deliver solutions to the public health threats we face. We are proud to be resuming production of COVID-19 vaccine batches following additional reviews and collaboration with the Food and Drug Administration and our manufacturing partner."

    Kramer added, "I am thankful for the relentless determination of our Emergent team across the globe to deliver for our patients, customers and partners."

    FINANCIAL HIGHLIGHTS (1)

    ($ in millions, except per share amounts)Q2 2021Q2 2020% Change
    Total revenues$397.5$394.71%
    Net income$4.6$92.7(95)%
    Net income per diluted share$0.09$1.73(95)%
    Adjusted net income (2)$18.0$105.7(83)%
    Adjusted net income (2) per diluted share$0.33$1.98(83)%
    Adjusted EBITDA (2)$49.5$156.1(68)%



    ($ in millions, except per share amounts)YTD 2021YTD 2020% Change
    Total revenues$740.5$587.226%
    Net income$74.3$80.2(7)%
    Net income per diluted share$1.37$1.51(9)%
    Adjusted net income (2)$101.6$106.0(4)%
    Adjusted net income (2) per diluted share$1.87$1.99(6)%
    Adjusted EBITDA (2)$173.0$171.41%

    Q2 2021 AND OTHER RECENT BUSINESS ACCOMPLISHMENTS

    • Announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it can resume production of Johnson & Johnson's COVID-19 vaccine bulk drug substance at the Company's Bayview manufacturing facility.
    • Supporting the U.S. government's smallpox preparedness efforts under contract options exercised by the Department of Health and Human Services (HHS) valued at approximately $182 million and $56 million to deliver ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) and VIGIV [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV), respectively.
    • Supporting the Canadian government's anthrax preparedness efforts under a new contract with the Public Health Agency Canada (PHAC) to deliver Anthrasil® (Anthrax Immune Globulin Intravenous [human]) through March 2023.
    • Received approval from the Federal Agency for Medicines and Health Products (FAMHP) of Belgium for Trobigard® Auto-injector (atropine sulfate 2mg/obidoxime chloride 220mg; solution for injection), an emergency treatment product for known or suspected exposure to nerve agents or toxic organophosphates in adults over 18 years of age.

    2021 FINANCIAL PERFORMANCE (1)

    (I) Quarter Ended June 30, 2021 (Q2)

    Revenues

    ($ in millions)Q2 2021Q2 2020% Change
    Product sales, net (3):
    • NARCAN® Nasal Spray
    $106.2$72.846%
    • Anthrax vaccines
    $51.5$132.3(61)%
    • ACAM2000
    $—$70.0(100)%
    • Other (4)
    $23.5$23.4—%
    Total product sales, net$181.2$298.5(39)%
    Contract development and manufacturing (CDMO) services$190.9$72.6*
    Contracts and grants$25.4$23.68%
    Total revenues$397.5$394.71%
    * % change is greater than 100%

    Product Sales, net

    NARCAN Nasal Spray

    For Q2 2021, revenues from NARCAN® (naloxone HCI) Nasal Spray increased $33.4 million as compared to Q2 2020. The increase is largely driven by a growth in sales to the U.S. public interest and commercial retail markets as well as an increase in sales to customer channels in Canada.

    Anthrax vaccines

    For Q2 2021, revenues from Anthrax vaccines decreased $80.8 million as compared to Q2 2020. The decrease is largely driven by timing of deliveries to the U.S. government.

    ACAM2000

    For Q2 2021, revenues from ACAM2000 decreased $70.0 million as compared to Q2 2020. The decrease is largely driven by the timing of deliveries to the U.S. government; the most recent option exercise was received in July 2021 valued at approximately $182 million, the entire amount of which is expected to be delivered in fiscal year 2021.

    Other (4)

    For Q2 2021, revenues from other product sales were consistent as compared to Q2 2020.

    Contract Development and Manufacturing (CDMO) Services

    For Q2 2021, revenue from contract development and manufacturing services increased $118.3 million, as compared to Q2 2020. The increase is due to the public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) and arrangements with pharma/biotech innovators to address the COVID-19 pandemic. These arrangements were entered into during the second and third quarters of 2020.

    Contracts and Grants

    For Q2 2021, revenues from contracts and grants were consistent as compared to Q2 2020.

    Operating Expenses

    ($ in millions)Q2 2021Q2 2020% Change
    Cost of product sales and CDMO services$227.8$129.876%
    Research and development$48.9$47.92%
    Selling, general and administrative$91.2$76.020%
    Amortization of intangible assets$15.1$15.01%

    Cost of Product Sales and CDMO Services

    For Q2 2021, cost of product sales and contract development and manufacturing services increased $98.0 million as compared to Q2 2020. The increase primarily consists of an increase in costs associated with the Company's contract development and manufacturing services due to higher volume of CDMO services, a majority of which were in support of the Company's arrangements to address the COVID-19 pandemic. Additionally, during the quarter the Company had inventory write-offs of $41.5 million associated with raw materials and in-process batches manufactured at the Company's Bayview facility that it plans to discard as they were deemed unusable. These increases were partially offset by decreases in the cost of product sales due to less volume.

    Research and Development

    For Q2 2021, research and development expenses were consistent as compared to Q2 2020.

    Selling, General and Administrative

    For Q2 2021, selling, general and administrative expenses increased $15.2 million as compared to Q2 2020. The increase is primarily due to an increase in costs related to defending and supporting the Company's corporate reputation.

    Additional Financial Information

    Gross Margin (2)

    ($ in millions)Q2 2021Q2 2020% Change
    Gross margin$144.3$241.3(40)%
    Gross margin % (gross margin divided by adjusted revenues (2))39%65%(26)%

    For Q2 2021, gross margin decreased $97.0 million as compared to Q2 2020. The decrease is primarily due to the increase in the cost of product sales and CDMO services, specifically $41.5 million associated with the inventory write-offs, $43.1 million associated with product and service revenue mix which was weighted more heavily to lower margin products and services, and $12.4 million associated with costs incurred to remediate and strengthen manufacturing processes at the Company's Bayview facility, many of which are considered temporary in nature.

    CDMO Metrics

    CDMO Backlog Rollforward ($ in millions)
    Beginning backlog (3/31/2021) (5)$1,342.8
    Revenue recognized during Q2 2021($190.9)
    New Business - Initial value of contracts secured during Q2 2021 (6)$53.2
    New Business - Incremental value of existing contracts modified during Q2 2021 (6)($108.1)
    Ending backlog (6/30/2021) (5)$1,097.0



    ($ in millions)June 30, 2021March 31, 2021% Change
    CDMO services backlog (5)$1,097.0$1,342.8(18)%
    CDMO services opportunity funnel (7)$672.0$807.1(17)%

    For Q2 2021, CDMO services backlog decreased $245.8 million as compared to Q1 2021. The decrease is primarily due to revenue realized in the quarter of $190.9 million, $108.1 million of negative contract modifications and other adjustments offset by $53.2 million of positive new business generation during the quarter.

    For Q2 2021, CDMO services opportunity funnel decreased $135.1 million as compared to Q1 2021. The decrease is primarily due to the exclusion of opportunities at the Company's Bayview facility as all manufacturing activities at that facility are currently prioritized to support the Johnson & Johnson COVID-19 vaccine.

    Capital Expenditures

    ($ in millions)Q2 2021Q2 2020% Change
    Gross capital expenditures$67.0$35.191%
    - Capital expenditures reimbursed$11.4$——%
    Net capital expenditures$55.6$35.158%
    Gross capital expenditures as a % of total revenues17%9%8%
    Net capital expenditures as a % of total revenues14%9%5%

    For Q2 2021, capital expenditures increased largely due to the Company's continued investments associated with increased capacity and capabilities at the Company's Rockville and Bayview facilities. The increase in gross capital expenditures was offset by reimbursements of $11.4 million related to arrangements funded by the U.S. government.

    2021 FINANCIAL FORECAST

    For full year 2021, the Company's forecast includes the following financial metrics:

    ($ in millions)2021 Forecast
    Total revenues$1,700 - $1,900Reaffirmed
    • NARCAN® Nasal Spray
    $305 - $325Reaffirmed
    • Anthrax vaccines
    $280 - $310Reaffirmed
    • ACAM2000®
    $185 - $205Reaffirmed
    • CDMO services
    $765 - $875Reaffirmed
    Adjusted EBITDA (2)$620 - $720Reaffirmed
    Adjusted net income (2)$395 - $470Reaffirmed
    Gross margin (2)61% - 63%Revised**
    ** Previous forecasted gross margin was 63% to 65%.

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

    Revised Considerations

    • Gross margin reflects the impact of the Q2 2021 performance as well as expectations for the remainder of the year.

    Unchanged Considerations

    • Narcan® Nasal Spray revenues assume the naloxone market remains competitive and incorporates the impact of at least one new branded entrant into the market by year end, as well as that no generic entrant will enter the market prior to the anticipated appellate decision related to the pending patent litigation, which is expected in the second half of 2021.
    • Anthrax vaccines revenues are expected to continue to primarily reflect procurement of AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted)​ under the terms of the Company's existing contract with BARDA at a more normalized annual level.
    • ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) vaccine revenues incorporate the expected full delivery of product under the $182 million option exercise received in July 2021 as well as other international sales.
    • CDMO services revenue reflects the successful manufacturing of Johnson & Johnson's COVID-19 vaccine bulk drug substance. On July 29, the Company announced that it was informed by the FDA that it can resume production at its Bayview manufacturing facility.
    • Total revenues, specifically other product sales, are expected to be impacted due to the Company's assumption that a new raxibacumab contract will be awarded later than previously planned.
    • R&D expenses are expected to reflect continued pipeline progress across the vaccines, therapeutics, and devices portfolios, including the assumption of 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.

    Q3 2021 REVENUE FORECAST

    For Q3 2021, the Company expects total revenues of $400 million to $500 million.

    FOOTNOTES

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

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

    (3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts.

    (4) Other can include a combination of sales of any of the following products: BAT, VIGIV, Anthrasil, raxibacumab, RSDL, Trobigard, Vivotif, and Vaxchora.

    (5) CDMO backlog is defined as estimated remaining contract value as of the indicated period pursuant to signed contracts, the majority of which is expected to be recognized over the next 24 months.

    (6) CDMO new business is defined as initial value of contracts secured as well as incremental value of existing contracts modified within the indicated period and is incorporated into Backlog.

    (7) CDMO opportunity funnel is defined as proposal values from new work with new customers, new work with existing customers and extensions/expansions of existing contracts with existing customers that, if converted to new business, the majority of which is expected to be realized over the next 24 months. This excludes any value associated with an extension of the commercial supply agreement (CSA) with Johnson & Johnson.

    CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION

    Company management will host a conference call at 5:00 pm (Eastern Time) today, July 29, 2021, 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: 1089625
     
    Live Webcast Information:

    Visit https://edge.media-server.com/mmc/p/yzfzc7j7 for the webcast.
     

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

    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 our website and follow us on LinkedIn, Twitter, and Instagram

    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 Revenues 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. For its non-GAAP measures, the Company adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges or accounting changes. As needed, such adjustments are tax effected utilizing the federal statutory tax rate for the U.S., except for changes in the fair value of contingent consideration as the vast majority is non-deductible for tax purposes. 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. For more information on these non-GAAP financial measures, please see the tables captioned "Reconciliation of Net Income to Adjusted Net Income," "Reconciliation of Net Income to Adjusted EBITDA," "Reconciliation of Gross Margin" and "Reconciliation of Net Research and Development Expenses" included at the end of this release.

    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 the strength of our strategy and diversified business model; annual expectations underlying gross margin; continued procurement of AV7909 under our existing contract with BARDA; the full delivery in 2021 of vaccines procured under the July 2021 ACAM2000® option exercise; the potential award of a new procurement contract for raxibacumab; the strength of the naloxone market and the timing and number of naloxone competitor entrants expected by year end; the timing of the anticipated appellate decision on related pending patent litigation; progress across the vaccines, therapeutics, and devices portfolios and anticipated timing and number of regulatory submissions; capacity expansion in our CDMO business portfolio; timing of CDMO revenues; our CDMO backlog and opportunity funnel; capital expenditures and total contract value; 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, product sales, government development or procurement contracts or awards, government appropriations, manufacturing capabilities, and the timing of certain clinical trials and regulatory approvals 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.

    The reader should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers 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 continued exercise of discretion by BARDA to procure additional doses of AV7909 prior to approval by the FDA; our ability to negotiate follow-on procurement contracts for AV7909 and other follow-on procurement contracts for our public health threat products that have expired or will be expiring; the impact on our revenues from the hold of certain COVID-19 vaccine bulk drug substance lots; our ability to meet our commitments to continued quality and manufacturing compliance at our Baltimore Bayview facility and the potential impact on our ability to continue production of bulk drug substance for Johnson & Johnson's COVID-19 vaccine at the facility; the availability of U.S. government funding for procurement of our products and certain product candidates; our ability to perform under our contracts with the U.S. government including the timing of and specifications relating to deliveries; our ability to provide CDMO services for the development and/or manufacture of product candidates of our customers at required levels and on required timelines; 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 and maintain regulatory approvals for our product candidates and the timing of any such approvals; changes to U.S. government priorities for the SNS and the future exercise of all remaining options under our contract for the procurement of ACAM2000® and other government procurement contracts; the negotiation of further commitments or contracts related to the collaboration and deployment of capacity toward future commercial manufacturing under our CDMO contracts; the timing of our submission of an application for and our ability to secure licensure of AV7909 from the FDA within the anticipated timeframe, if at all; our ability to successfully appeal the patent litigation decision related to NARCAN® Nasal Spray 4mg/spray, and the impact of competition from potential generic and branded naloxone entrants on NARCAN® Nasal Spray; the results of pending shareholder litigation and the potential impact on our business; our ability to develop a safe and effective treatment for COVID-19 and obtain authorization for emergency use for or approval of such treatment from the FDA; our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria; our ability to comply with the operating and financial covenants required by our senior secured credit facilities and our 3.875% Senior Unsecured Notes due 2028; 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 full impact of COVID-19 disease on our markets, operations and employees as well as those of our customers and suppliers; the impact on our revenues from short-term declines in sales of our vaccine products that target travelers due to the reduction of international travel caused by the COVID-19 pandemic; the success of our commercialization, marketing and manufacturing capabilities and strategy; and the accuracy of our estimates regarding future revenues, expenses, 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. The reader 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

     

    (240) 413-1917
    Media Contact

    Matt Hartwig

    Director, Media Relations

                                                    

    (240) 760-0551



    Emergent BioSolutions Inc.
    Condensed Consolidated Balance Sheets
    (unaudited, in millions, except per share data)
        
     June 30, 2021 December 31, 2020
    ASSETS   
    Current assets:   
    Cash and cash equivalents$447.5  $621.3 
    Restricted cash0.2  0.2 
    Accounts receivable, net261.9  230.9 
    Inventories, net386.4  307.0 
    Prepaid expenses and other current assets66.1  36.5 
    Total current assets1,162.1  1,195.9 
        
    Property, plant and equipment, net743.5  644.1 
    Intangible assets, net633.1  663.1 
    Goodwill266.6  266.7 
    Other assets109.9  113.4 
    Total assets$2,915.2  $2,883.2 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$151.8  $136.1 
    Accrued expenses33.8  46.9 
    Accrued compensation63.2  84.6 
    Debt, current portion28.8  33.8 
    Other current liabilities100.2  83.1 
    Total current liabilities377.8  384.5 
        
    Contingent consideration, net of current portion5.0  34.2 
    Debt, net of current portion825.2  841.0 
    Deferred tax liability53.2  53.2 
    Contract liabilities, net of current portion48.9  55.5 
    Other liabilities61.4  67.8 
    Total liabilities$1,371.5  $1,436.2 
        
    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, 54.9 and 54.3 shares issued; 53.7 and 53.1 shares outstanding, respectively0.1  0.1 
    Additional paid-in capital804.4  784.9 
    Treasury stock, at cost, 1.2 common shares(39.6) (39.6)
    Accumulated other comprehensive loss, net(22.4) (25.3)
    Retained earnings801.2  726.9 
    Total stockholders' equity1,543.7  1,447.0 
    Total liabilities and stockholders' equity$2,915.2  $2,883.2 



    Emergent BioSolutions Inc.
    Condensed Consolidated Statements of Operations
    (unaudited, in millions, except per share data)
             
     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020  2021  2020 
          
    Revenues:        
    Product sales, net$181.2 $298.5 $319.1 $446.7 
    Contract development and manufacturing services 190.9  72.6  374.7  94.3 
    Contracts and grants 25.4  23.6  46.7  46.2 
    Total revenues 397.5  394.7  740.5  587.2 
             
    Operating expenses:        
    Cost of product sales and contract development and manufacturing services 227.8  129.8  327.1  206.7 
    Research and development 48.9  47.9  101.4  90.6 
    Selling, general and administrative 91.2  76.0  172.1  145.7 
    Amortization of intangible assets 15.1  15.0  30.0  29.8 
    Total operating expenses 383.0  268.7  630.6  472.8 
             
    Income from operations 14.5  126.0  109.9  114.4 
             
    Other income (expense):        
    Interest expense (8.6) (6.4) (17.1) (15.0)
    Other, net 1.3  1.1  (0.4)  
    Total other income (expense), net (7.3) (5.3) (17.5) (15.0)
             
    Income before income taxes 7.2  120.7  92.4  99.4 
    Income taxes (2.6) (28.0) (18.1) (19.2)
    Net income$4.6 $92.7 $74.3 $80.2 
             
    Net income per common share*        
    Basic$0.09 $1.76 $1.40 $1.53 
    Diluted$0.09 $1.73 $1.37 $1.51 
             
    Shares used in computing income per share        
    Basic 53.6  52.6  53.5  52.3 
    Diluted 54.0  53.5  54.3  53.2 
             
    * Any differences in the calculation of net income per common share is due to rounding.
     

    Emergent BioSolutions Inc.

    Condensed Consolidated Statements of Cash Flows

    (unaudited, in millions)

     Six Months Ended June 30,
     2021 2020
    Cash flows (used in) provided by operating activities:   
    Net income$74.3  $80.2 
    Adjustments to reconcile to net income to net cash (used in) provided by operating activities:   
    Share-based compensation expense21.9  31.0 
    Depreciation and amortization61.9  56.8 
    Change in fair value of contingent consideration, net1.7  1.1 
    Amortization of deferred financing costs2.0  1.5 
    Deferred income taxes(3.2) (3.7)
    Other2.0  1.1 
    Changes in operating assets and liabilities:   
    Accounts receivable(34.7) 12.1 
    Inventories(79.7) (13.7)
    Prepaid expenses and other assets(2.4) (16.9)
    Accounts payable8.0  (14.5)
    Accrued expenses and other liabilities(55.4) 25.0 
    Accrued compensation(21.4) (3.4)
    Contract liabilities0.4  29.1 
    Net cash (used in) provided by operating activities:(24.6) 185.7 
    Cash flows used in investing activities:   
    Purchases of property, plant and equipment(123.1) (59.3)
    Milestone payment from prior asset acquisition  (10.0)
    Net cash used in investing activities:(123.1) (69.3)
    Cash flows used in financing activities:   
    Principal payments on revolving credit facility  (20.0)
    Principal payments on term loan facility(11.3) (5.6)
    Principal payments on convertible senior notes(10.6)  
    Proceeds from share-based compensation activity10.0  23.1 
    Taxes paid for share-based compensation activity(13.0) (11.7)
    Contingent consideration payments(1.1) (1.1)
    Net cash used in financing activities:(26.0) (15.3)
    Effect of exchange rate changes on cash, cash equivalents and restricted cash(0.1) (0.1)
    Net change in cash, cash equivalents and restricted cash(173.8) 101.0 
    Cash, cash equivalents and restricted cash at beginning of period621.5  168.0 
    Cash, cash equivalents and restricted cash at end of period$447.7  $269.0 
        

    Reconciliation of Net Income to Adjusted Net Income (1)

     Three Months Ended June 30,
    ($ in millions, except per share value)20212020Source
    Net income$4.6$92.7 
    Adjustments:
    + Non-cash amortization charges16.115.8Intangible Asset (IA) Amortization, Other Income
    + Changes in fair value of contingent consideration0.60.5COGS
    + Acquisition-related costs (transaction & integration)0.1SG&A
    Tax effect(3.4)(3.3) 
    Total adjustments:$13.4$13.0 
    Adjusted net income$18.0$105.7 
    Adjusted net income per diluted share$0.33$1.98 



     Six Months Ended June 30,
    ($ in millions, except per share value)20212020Source
    Net income$74.3$80.2 
    Adjustments:
    + Non-cash amortization charges32.131.3Intangible Asset (IA) Amortization, Other Income
    + Changes in fair value of contingent consideration1.71.1COGS
    + Acquisition-related costs (transaction & integration)0.3SG&A
    Tax effect(6.8)(6.6) 
    Total adjustments:$27.3$25.8 
    Adjusted net income$101.6$106.0 
    Adjusted net income per diluted share$1.87$1.99 



    ($ in millions)Reaffirmed 2021 Full Year

    Forecast
    Source
    Net income$340 - $415 
    Adjustments:
    + Non-cash amortization charges64IA Amortization, Other Income
    + Changes in fair value of contingent consideration3COGS
    + Acquisition-related costs (transaction & integration)2SG&A
    Tax effect(14) 
    Total adjustments:$55 
    Adjusted net income$395 - $470 

    Reconciliation of Net Income to Adjusted EBITDA (1)

     Three Months Ended June 30,
    ($ in millions)20212020
    Net income$4.6$92.7
    Adjustments:
    + Depreciation & amortization33.228.6
    + Provision for income taxes2.628.0
    + Total interest expense, net8.46.3
    + Changes in fair value of contingent consideration0.60.5
    + Acquisition-related costs (transaction & integration)0.1
    Total adjustments$44.9$63.4
    Adjusted EBITDA$49.5$156.1



     Six Months Ended June 30,
    ($ in millions)20212020
    Net income$74.3$80.2
    Adjustments:
    + Depreciation & amortization61.956.8
    + Provision for income taxes18.119.2
    + Total interest expense, net16.714.1
    + Changes in fair value of contingent consideration1.71.1
    + Acquisition-related costs (transaction & integration)0.3
    Total adjustments$98.7$91.2
    Adjusted EBITDA$173.0$171.4



    ($ in millions)Reaffirmed 2021 Full Year

    Forecast
    Net income$340 - $415
    Adjustments:
    + Depreciation & amortization129
    + Provision for income taxes114-139
    + Total interest expense, net32
    + Changes in fair value of contingent consideration3
    + Acquisition-related costs (transaction & integration)2
    Total adjustments$280 - $305
    Adjusted EBITDA$620 - $720

    Reconciliation of Gross Margin (1)

     Three Months Ended June 30,
    ($ in millions)20212020
    Total revenues$397.5$394.7
    - Contract and grants revenues(25.4)(23.6)
    Adjusted revenues$372.1$371.1
       
    Cost of product sales and contract development and manufacturing services ("COGS")$227.8$129.8
       
    Gross margin (adjusted revenues minus COGS)$144.3$241.3
    Gross margin % (gross margin divided by adjusted revenues)39%65%



     Six Months Ended June 30,
    ($ in millions)20212020
    Total revenues$740.5$587.2
    - Contract and grants revenues(46.7)(46.2)
    Adjusted revenues$693.8$541.0
       
    Cost of product sales and contract development and manufacturing services ("COGS")$327.1$206.7
       
    Gross margin (adjusted revenues minus COGS)$366.7$334.3
    Gross margin % (gross margin divided by adjusted revenues)53%62%

    Reconciliation of Net Research and Development Expenses (1)

     Three Months Ended June 30,
    ($ in millions)20212020
    Research and Development Expenses$48.9$47.9
    Adjustments:
    - Contracts and Grants Revenue(25.4)(23.6)
    Net Research and Development Expenses23.5$24.3
    Adjusted Revenue

    (Total Revenue less Contracts and Grants Revenue)
    372.1$371.1
    Net R&D as % of Adjusted Revenue (Net R&D Margin)6%7%



     Six Months Ended June 30,
    ($ in millions)20212020
    Research and Development Expenses$101.4$90.6
    Adjustments:
    - Contracts and Grants Revenue(46.7)(46.2)
    Net Research and Development Expenses54.7$44.4
    Adjusted Revenue

    (Total Revenue less Contracts and Grants Revenue)
    693.8$541.0
    Net R&D as % of Adjusted Revenue (Net R&D Margin)8%8%

     



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  1. GAITHERSBURG, Md., July 29, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) is allowing Emergent's Bayview manufacturing facility to resume production of Johnson & Johnson's (J&J) Covid-19 vaccine bulk drug substance. This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent's quality enhancement plan.

    "We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners," said Emergent chief executive officer, Robert Kramer. "We are in the unique business of producing life-saving…

    GAITHERSBURG, Md., July 29, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) is allowing Emergent's Bayview manufacturing facility to resume production of Johnson & Johnson's (J&J) Covid-19 vaccine bulk drug substance. This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent's quality enhancement plan.

    "We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners," said Emergent chief executive officer, Robert Kramer. "We are in the unique business of producing life-saving medications for catastrophes that we hope never occur like anthrax attacks, opioid overdoses, and Covid-19."

    Since production was paused at Bayview, Emergent has worked closely with FDA and J&J to address quality concerns including developing and executing an action plan and committing extensive resources to bring operations up to FDA's exacting standards. Emergent expects to continue to work with FDA throughout the manufacturing process to help ensure the strength of the J&J Covid-19 vaccine supply chain.

    "The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves," said Kramer. "We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end. We'd like to thank our government partners as well as Johnson & Johnson for their support."

    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.

    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 meet the FDA's exacting standards, ensuring the strength of J&J's supply chain, receipt of EUA from the FDA for the Bayview facility and any other statements containing the words "believes," "expects," "anticipates," "intends," "plans," "estimates," and similar expressions, 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. The reader should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers 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 Emergent's actual results to differ materially from those indicated by such forward-looking statements, including our ability to maintain production at FDA standards and receive EUA for our Bayview facility. 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. The reader 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.

    Contacts:

    Media:

    Matt Hartwig

    Director, Media Relations

    (240) 760-0551

     

    Investors:

    Robert G. Burrows

    Vice President, Investor Relations

    (240) 631-3280

     



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    • Emergent BioSolutions joins forces with an alliance of advocacy organizations that share a common goal to empower open communication and address the stigma of opioid overdoses, which are oftentimes accidental.
    • Professional football player Darren Waller and lifestyle influencer Dani Schaffer openly share their stories of addiction, overdose and tragedy in new television and radio spots airing across the country.
    • New data from the U.S. Centers for Disease Control and Prevention (CDC) reported that over 93,000 Americans lost their lives to a drug overdose in 2020 amidst the COVID-19 pandemic, of which 8 in 10 deaths involved opioids, including prescription opioids (natural and semi-synthetic opioids, and methadone), heroin, and synthetic opioids…
    • Emergent BioSolutions joins forces with an alliance of advocacy organizations that share a common goal to empower open communication and address the stigma of opioid overdoses, which are oftentimes accidental.

    • Professional football player Darren Waller and lifestyle influencer Dani Schaffer openly share their stories of addiction, overdose and tragedy in new television and radio spots airing across the country.
    • New data from the U.S. Centers for Disease Control and Prevention (CDC) reported that over 93,000 Americans lost their lives to a drug overdose in 2020 amidst the COVID-19 pandemic, of which 8 in 10 deaths involved opioids, including prescription opioids (natural and semi-synthetic opioids, and methadone), heroin, and synthetic opioids (primarily illicit fentanyl).

    GAITHERSBURG, Md., July 26, 2021 (GLOBE NEWSWIRE) --  An alliance of national nonprofit organizations comprised of Community Anti-Drug Coalitions of America (CADCA), Mothers Against Prescription Drug Abuse (MAPDA), SAFE Project, and Shatterproof, sponsored by Emergent BioSolutions Inc., (NYSE:EBS) today announced the launch of a new public awareness campaign, Reverse the Silence, which features television and radio spots that educate and help support people who may be at risk or know someone at risk of an opioid overdose.

    Lifestyle influencer Dani Schaffer, who lost her brother, Scott Anthony Molinari, to an accidental overdose in 2018 at the age of 33, is using her platform to talk about opioid use and ways to be prepared for an overdose emergency. And professional athlete Darren Waller, who for many years lived with an opioid dependency that started at a young age, is now sharing his story of struggle and triumph after overdosing in his car in 2017.

    "At the age of 15, I was introduced to opioids and developed a dependency that helped mask how I felt on the inside, but the reality is that I felt completely isolated, and no one knew what I was going through," said Waller. "Reverse the Silence means no longer remaining quiet and allowing others to dictate the narrative for those of us who are living with addiction or are on the journey to recovery. I'm telling my story because too many lives have been lost to overdoses."

    An accidental opioid overdose can happen to anyone taking opioids, across any community. The CDC's 2020 provisional data found a substantial increase in drug overdose deaths across the country that coincided with the implementation of widespread mitigation measures for the COVID-19 pandemic. According to the CDC, over 93,000 drug overdose deaths occurred in the 12-month period ending in December 2020, representing a worsening of the drug overdose epidemic and the largest number of drug overdoses for a 12-month period ever recorded.

    "Hundreds of thousands of lives have already been lost and it's our responsibility to help reverse the silence about opioid use and the risks of accidental opioid overdose," said Admiral James and Mary Winnefeld, founders of SAFE Project, and representatives of the alliance. "We have joined forces with Emergent BioSolutions because we cannot sit back and lose another life needlessly when there are tools and ways to be prepared to help prevent an opioid overdose. We encourage every family to talk about it and build a plan for an opioid overdose emergency, because accidents happen, and every second matters when someone's life is on the line."

    Of the 49 million patients prescribed opioids in the U.S., more than 18 million are considered at risk, which includes patients prescribed opioids who are concurrently taking benzodiazepines, those with a history of opioid use disorder or prior opioid overdoses. It's important to remember those who have household members, including children, or other close contacts who may be at risk for accidental ingestion or overdose.

    "We are facing an opioid epidemic that is ravaging our society as evidenced by the growing number of fatal opioid overdoses happening every day," said Doug White, SVP and devices business unit head at Emergent BioSolutions. "We are proud to team up with Dani Schaffer, Darren Waller, and this alliance of national nonprofit organizations to help reverse the silence and lessen the stigma of opioid overdoses, which are often accidental."

    For more information about Reverse the Silence and how to help stop overdoses, visit ReverseSilence.org.

    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.

    About The Alliance

    The Alliance was formed between Community Anti-Drug Coalitions of America (CADCA), Mothers Against Prescription Drug Abuse (MAPDA), SAFE Project and Shatterproof. These national nonprofit organizations share a commitment to combat drug abuse and to spare other Americans of the opioid epidemic that has devastated so many communities across the country. Visit the links provided to learn more about each organization.

    Emergent BioSolutions Contacts:

    Media:

    Matt Hartwig

    Director, Media Relations

    240-760-0551

    Investors:

    Robert G. Burrows

    Vice President, Investor Relations

    240-631-3280

     

    Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cee06727-cf4f-459d-aabd-0b896954ae2c

    https://www.globenewswire.com/NewsRoom/AttachmentNg/c88f85dd-ac62-4c6e-987e-db5b060e2f00

    https://www.globenewswire.com/NewsRoom/AttachmentNg/3052cc92-1378-4f69-ae70-e55f4212483f

    Videos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/746c412c-b4ab-42fc-a307-413e9335df2b

    https://www.globenewswire.com/NewsRoom/AttachmentNg/cdb062d4-4831-4d99-beef-72392b956dd6

    https://www.globenewswire.com/NewsRoom/AttachmentNg/13a4ad02-e8c5-425c-aec8-4ae58dbd145d

    https://www.globenewswire.com/NewsRoom/AttachmentNg/1492fd7f-00f2-45ff-bd4f-d6e60e2c22b8



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  2. GAITHERSBURG, Md., July 15, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) will host a conference call on Thursday, July 29, 2021 at 5:00 pm eastern time to discuss the financial results for the second quarter of 2021, recent business developments, revenue guidance for the third quarter of 2021, and financial outlook for full year 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: 1089625

    Webcast Information:
    Visit https://edge.media-server.com/mmc/p/yzfzc7j7 for the live webcast.

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

    About Emergent BioSolutions
    Emergent…

    GAITHERSBURG, Md., July 15, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) will host a conference call on Thursday, July 29, 2021 at 5:00 pm eastern time to discuss the financial results for the second quarter of 2021, recent business developments, revenue guidance for the third quarter of 2021, and financial outlook for full year 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: 1089625



    Webcast Information:

    Visit https://edge.media-server.com/mmc/p/yzfzc7j7 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

    Media Contact:

    Matt Hartwig

    Director, Media Relations



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    • Emergent continues to work with the FDA to address identified observations at Bayview facility in order to release additional batches and resume production

    GAITHERSBURG, Md., June 11, 2021 (GLOBE NEWSWIRE) --  Emergent BioSolutions Inc. (NYSE:EBS) today announced that two batches of COVID-19 vaccine manufactured by Emergent BioSolutions at its Baltimore Bayview facility were determined to be suitable for use by the U.S. Food & Drug Administration (FDA) and have been authorized as part of Johnson & Johnson's Emergency Use Authorization (EUA).

    "We are pleased that these initial doses of the Johnson & Johnson COVID-19 vaccine will be available to protect millions of people from this deadly disease," said Robert G. Kramer, president and chief…

    • Emergent continues to work with the FDA to address identified observations at Bayview facility in order to release additional batches and resume production

    GAITHERSBURG, Md., June 11, 2021 (GLOBE NEWSWIRE) --  Emergent BioSolutions Inc. (NYSE:EBS) today announced that two batches of COVID-19 vaccine manufactured by Emergent BioSolutions at its Baltimore Bayview facility were determined to be suitable for use by the U.S. Food & Drug Administration (FDA) and have been authorized as part of Johnson & Johnson's Emergency Use Authorization (EUA).

    "We are pleased that these initial doses of the Johnson & Johnson COVID-19 vaccine will be available to protect millions of people from this deadly disease," said Robert G. Kramer, president and chief executive officer of Emergent. "We look forward to working with the FDA and Johnson & Johnson toward the release of additional batches and resuming production at our Bayview facility."

    Emergent is actively addressing issues identified by the FDA at its Bayview facility and plans to resume manufacturing of the Johnson & Johnson COVID-19 vaccine drug substance after Emergent, Johnson & Johnson, and FDA are confident that the steps taken have remedied shortcomings.

    For nearly a decade, Emergent has been working closely with the U.S. government to ensure that manufacturing capacity stands at the ready to address public health emergencies. This foresight of the U.S. government led to the designation of Emergent's Baltimore Bayview facility as a Center for Innovation in Advanced Development and Manufacturing (CIADM) in 2012. This agreement was first established as a public-private partnership for influenza pandemic preparedness. Since mid-2020, Emergent has harnessed its capabilities to rapidly build and scale up capacity to manufacture bulk drug substance for Johnson & Johnson's COVID-19 vaccine.

    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.

    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 manufacturing capacity and supply and vaccination goals and any other statements containing the words "believes," "expects," "anticipates," "intends," "plans," "estimates," and similar expressions, 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 our ability to produce vaccine bulk drug substance on a timely basis and in sufficient quantities to meet demand. 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:

    Matt Hartwig

    Director, Media Relations

    Investor Contact:

    Robert G. Burrows

    Vice President, Investor Relations



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