EBS Emergent Biosolutions Inc.

110.06
+2.19  (+2%)
Previous Close 107.87
Open 107.75
52 Week Low 46.37
52 Week High 137.61
Market Cap $5,833,085,238
Shares 52,999,139
Float 37,994,626
Enterprise Value $6,181,417,123
Volume 500,933
Av. Daily Volume 581,111
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
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.
CHIKV-VLP
Chikungunya virus
Phase 2
Phase 2
Phase 3 trial to be initiated in 2021.
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

    • 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



    Primary Logo

    View Full Article Hide Full Article
  1. 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



    Primary Logo

    View Full Article Hide Full Article
  2. 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





    Primary Logo

    View Full Article Hide Full Article
    • 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% 



    Primary Logo

    View Full Article Hide Full Article
  3. 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

    Primary Logo

    View Full Article Hide Full Article
View All Emergent Biosolutions Inc. News