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Emergent BioSolutions(EBS) - 2022 Q1 - Earnings Call Transcript
2022-04-29 01:47
Emergent BioSolutions Inc. (NYSE:EBS) Q1 2022 Results Conference Call April 28, 2022 5:00 PM ET Company Participants Bob Burrows - VP, IR Bob Kramer - President and CEO Rich Lindahl - CFO Conference Call Participants Brandon Folkes - Cantor Fitzgerald Lisa Springer - Singular Research Operator Good day, and thank you for standing by. Welcome to the First Quarter 2022 Emergent BioSolutions Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, ther ...
Emergent BioSolutions(EBS) - 2022 Q1 - Quarterly Report
2022-04-28 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33137 | --- | --- | --- | --- | --- | |----------------------------------------------------------------------------|----------- ...
Emergent BioSolutions(EBS) - 2021 Q4 - Earnings Call Transcript
2022-02-25 03:04
Emergent BioSolutions Inc. (NYSE:EBS) Q4 2021 Earnings Conference Call February 24, 2022 5:00 PM ET Company Participants Bob Burrows - IR Officer Bob Kramer - President and CEO Rich Lindahl - CFO Adam Havey - Chief Operating Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Jessica Fye - JPMorgan Jacob Hughes - Wells Fargo Keay Nakae - Chardan Lisa Springer - Singular Research Operator Good day, and thank you for standing by. Welcome to the Q4 2021 Emergent BioSolutions Incorporated Ea ...
Emergent BioSolutions(EBS) - 2021 Q4 - Annual Report
2022-02-24 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K 400 Professional Drive, Suite 400 (Address of Principal Executive Offices) Gaithersburg MD 20879 (City) (State) (Zip Code) (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33137 EME ...
Emergent BioSolutions(EBS) - 2021 Q3 - Quarterly Report
2021-11-04 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001 ...
Emergent BioSolutions(EBS) - 2021 Q2 - Earnings Call Transcript
2021-07-30 02:39
Financial Data and Key Metrics Changes - Total revenues for Q2 2021 were $398 million, an increase of $3 million compared to the prior year, consistent with guidance [29] - Adjusted EBITDA was $50 million and adjusted net income was $18 million, both showing decreases from the prior year due to various one-time expenses [29] - Cost of goods sold increased by $98 million to $228 million, reflecting higher costs associated with increased CDMO services revenues and $42 million in inventory write-offs [31] Business Line Data and Key Metrics Changes - Anthrax vaccine sales were $52 million lower than the prior year due to timing of deliveries [30] - NARCAN nasal spray sales reached $106 million, an increase driven by strong demand for opioid overdose reversal products [30] - CDMO services revenue was $191 million, reflecting contributions from all service pillars, primarily due to COVID-19 pandemic responses [30] Market Data and Key Metrics Changes - The backlog for CDMO services stood at $1.1 billion as of June 30, with an opportunity funnel of $672 million, down from $807 million at the end of Q1 [34] - The U.S. government exercised the next ACAM2000 contract option valued at approximately $182 million, with deliveries expected by the end of 2021 [31] Company Strategy and Development Direction - The company is in the second year of its 2020-2024 strategic plan, focusing on public health threats while diversifying its customer base beyond the U.S. government [13][20] - Continued collaboration with AstraZeneca and Johnson & Johnson to enhance drug substance production and address public health needs [12][21] - The company is advancing its pipeline of medical countermeasures, including a COVID-HIG candidate and a Trobigard auto-injector [15][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's resilience and ability to meet public health challenges, emphasizing the importance of quality improvements at the Bayview facility [10][26] - The FDA's approval to resume production at Bayview is seen as a significant milestone for future operations [10][39] - The company reaffirmed its 2021 outlook, anticipating total revenue guidance of $400 million to $500 million for Q3 [39] Other Important Information - The company has a strong liquidity position with $448 million in cash and $262 million in accounts receivable, totaling nearly $710 million in current liquid assets [37] - A reorganization of the management team was announced to better position the company for long-term success [23][25] Q&A Session Summary Question: Can you provide color on the $108 million negative contract modification in the CDMO backlog? - Management indicated that the majority of the negative contract modifications were related to the wind down of work at Bayview with AstraZeneca, along with other ordinary course changes [44] Question: Will there be an update on long-term guidance for 2021? - Management is undergoing a strategy refresh and plans to provide updates either later this year or early next year [47] Question: What are the assumptions behind the NARCAN revenue guidance? - Management expects some tailwinds and headwinds impacting NARCAN revenue, setting guidance at $305 million to $325 million for 2021 [52] Question: Is there potential for M&A activity in the second half of the year? - Management is actively looking for strategic M&A opportunities while maintaining a strong liquidity position [59]
Emergent BioSolutions(EBS) - 2021 Q2 - Quarterly Report
2021-07-29 16:00
[Part I. Financial Information](index=5&type=section&id=Part%20I.%20Financial%20Information) This section provides unaudited condensed consolidated financial statements, management's analysis of financial condition, market risk disclosures, and internal controls assessment [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Emergent BioSolutions Inc. as of June 30, 2021, including balance sheets, statements of operations, comprehensive income, cash flows, and changes in stockholders' equity, with accompanying notes on operations, accounting policies, revenue recognition, debt, and legal contingencies Condensed Consolidated Balance Sheet Highlights (as of June 30, 2021) | Account | June 30, 2021 (in millions) | December 31, 2020 (in millions) | | :--- | :--- | :--- | | **Total Assets** | **$2,915.2** | **$2,883.0** | | Cash and cash equivalents | $447.5 | $621.0 | | Inventories, net | $386.4 | $307.0 | | Total current assets | $1,162.1 | $1,195.0 | | **Total Liabilities** | **$1,371.5** | **$1,436.0** | | Debt, current portion | $28.8 | $33.0 | | Debt, net of current portion | $825.2 | $841.0 | | **Total Stockholders' Equity** | **$1,543.7** | **$1,447.0** | Condensed Consolidated Statements of Operations Highlights | Metric | Three Months Ended June 30, 2021 (in millions) | Three Months Ended June 30, 2020 (in millions) | Six Months Ended June 30, 2021 (in millions) | Six Months Ended June 30, 2020 (in millions) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | **$397.5** | **$394.7** | **$740.5** | **$587.0** | | Product sales, net | $181.2 | $298.5 | $319.1 | $446.0 | | CDMO services | $190.9 | $72.6 | $374.7 | $94.0 | | **Income from operations** | **$14.5** | **$126.0** | **$109.9** | **$114.0** | | **Net Income** | **$4.6** | **$92.7** | **$74.3** | **$80.0** | | **Diluted EPS** | **$0.09** | **$1.73** | **$1.37** | **$1.50** | Condensed Consolidated Statements of Cash Flows Highlights (Six Months Ended June 30) | Cash Flow Activity | 2021 (in millions) | 2020 (in millions) | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(24.6) | $185.7 | | Net cash used in investing activities | $(123.1) | $(69.3) | | Net cash used in financing activities | $(26.0) | $(15.3) | | **Net change in cash** | **$(173.8)** | **$101.0** | - The company recorded an inventory write-off of **$41.5 million** at its Bayview facility during the three and six months ended June 30, 2021, due to unusable raw materials and in-process batches, charged to cost of product sales and CDMO services[49](index=49&type=chunk) - The company is involved in several legal proceedings, including class action lawsuits alleging materially false and misleading information about its COVID-19 vaccine manufacturing capabilities, a stockholder derivative lawsuit, and inquiries from multiple government bodies[106](index=106&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion highlights a significant shift in revenue composition for the first half of 2021, with total revenue growing 26% year-over-year driven by a substantial increase in Contract Development and Manufacturing (CDMO) services related to the COVID-19 pandemic, offsetting a 29% decline in product sales, while operating income saw a slight decline due to increased cost of services and higher SG&A expenses, and the company's cash position decreased due to negative working capital changes and increased capital expenditures Revenue Breakdown (Six Months Ended June 30) | Revenue Source | 2021 (in millions) | 2020 (in millions) | % Change | | :--- | :--- | :--- | :--- | | NARCAN Nasal Spray | $180.4 | $145.0 | 24% | | Anthrax vaccines | $106.5 | $184.2 | (42)% | | ACAM2000 | $0.0 | $70.0 | (100)% | | Other product sales | $32.2 | $47.5 | (32)% | | **Total product sales, net** | **$319.1** | **$446.7** | **(29)%** | | CDMO services | $374.7 | $94.3 | 297% | | Contracts and grants | $46.7 | $46.2 | 1% | | **Total Revenues** | **$740.5** | **$587.2** | **26%** | - The significant increase in CDMO services revenue for Q2 and H1 2021 is attributed to the public-private partnership with BARDA and arrangements with innovators to address the COVID-19 pandemic, initiated in mid-2020[151](index=151&type=chunk) - Cost of product sales and CDMO services increased primarily due to higher volume of CDMO services for COVID-19 and a **$41.5 million** inventory write-off at the Bayview facility for unusable raw materials and in-process batches[156](index=156&type=chunk) - Net cash used in operating activities was **$24.6 million** for the first six months of 2021, a sharp contrast to the **$185.7 million** provided by operations in the same period of 2020, driven by negative working capital changes, including inventory accumulation and increased receivables[167](index=167&type=chunk)[168](index=168&type=chunk) - Cash used in investing activities increased to **$123.1 million** from **$69.3 million** year-over-year, largely due to infrastructure and equipment investments to expand capacity and capabilities at the Rockville and Bayview facilities[169](index=169&type=chunk)[170](index=170&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from interest rates and foreign currency exchange rates, managing interest rate risk through a mix of fixed and variable rate debt and derivative instruments, and foreign currency risk primarily from the Euro, Canadian dollar, Swiss franc, and British pound through hedging transactions or incurring local currency operating expenses - The company has debt with both fixed and variable interest rates, with the impact of interest rate changes on variable debt managed through interest rate swap arrangements[181](index=181&type=chunk) - A hypothetical one percentage point increase in the eurocurrency rate as of June 30, 2021, would increase the company's annual interest expense by approximately **$0.6 million**[181](index=181&type=chunk) - The company has exposure to foreign currency fluctuations, primarily with the Euro, Canadian dollar, Swiss franc, and British pound, and manages this risk through hedging or incurring expenses in local currencies[181](index=181&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures as of June 30, 2021, concluding that these controls were effective at a reasonable assurance level, with no material changes in internal control over financial reporting during the quarter - As of June 30, 2021, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[181](index=181&type=chunk) - No changes occurred during the quarter ended June 30, 2021, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[181](index=181&type=chunk) [Part II. Other Information](index=33&type=section&id=Part%20II.%20Other%20Information) This section covers legal proceedings, key risk factors, equity sales, defaults, mine safety, other disclosures, and filed exhibits [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 14 of the financial statements, detailing ongoing legal matters including securities class action lawsuits and a stockholder derivative suit related to the company's COVID-19 vaccine manufacturing, responses to government inquiries, and patent litigation concerning generic versions of NARCAN® Nasal Spray - The company is facing multiple class action and stockholder derivative lawsuits related to its capabilities to manufacture COVID-19 vaccine bulk drug substance[106](index=106&type=chunk)[108](index=108&type=chunk) - Emergent is involved in ongoing patent infringement litigation against Teva Pharmaceuticals regarding generic versions of both 4mg and 2mg NARCAN® Nasal Spray[111](index=111&type=chunk)[114](index=114&type=chunk)[116](index=116&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks to the company's business, including the material adverse impact of the COVID-19 pandemic, heavy reliance on U.S. government contracts, manufacturing compliance issues, challenges in product development and commercialization, extensive regulatory oversight, potential competition for key products, and various financial, legal, and reputational risks - **Global Pandemic Risk:** The COVID-19 pandemic poses risks of manufacturing disruptions, supply chain interruptions, and decreased demand for travel health vaccines[189](index=189&type=chunk) - **Government Contracting Risk:** A substantial portion of revenue is derived from USG procurement of AV7909 and ACAM2000, and reduced demand or funding for these products would materially harm the business[195](index=195&type=chunk) - **Manufacturing Risk:** An inability to maintain quality and manufacturing compliance at the Baltimore Bayview facility could hinder production of Johnson & Johnson's COVID-19 vaccine, following an FDA inspection that identified cross-contamination and other issues[209](index=209&type=chunk) - **Competitive Risk:** NARCAN® Nasal Spray faces potential competition from both new branded products (like Kloxxado) and generic versions, with ongoing ANDA litigation against Teva[274](index=274&type=chunk)[277](index=277&type=chunk) - **Legal and Reputational Risk:** The company faces pending class action and derivative lawsuits regarding its vaccine production quality controls and has been subject to criticism from media and government, which could harm its reputation and stock price[296](index=296&type=chunk)[299](index=299&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=64&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities, no specific use of proceeds to report, and no purchases of equity securities by the company during the reporting period - The company reports no unregistered sales of equity securities, use of proceeds, or purchases of its equity securities for the period[321](index=321&type=chunk)[322](index=322&type=chunk)[323](index=323&type=chunk) [Item 3. Defaults Upon Senior Securities](index=64&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable, indicating no defaults upon senior securities occurred during the period - Not applicable; no defaults upon senior securities were reported[324](index=324&type=chunk) [Item 4. Mine Safety Disclosures](index=64&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports that this item is not applicable - Not applicable[324](index=324&type=chunk) [Item 5. Other Information](index=64&type=section&id=Item%205.%20Other%20Information) The company reports that this item is not applicable, indicating no other material information was required to be disclosed for the period - Not applicable[324](index=324&type=chunk) [Item 6. Exhibits](index=64&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, as required by Item 601 of Regulation S-K, including modifications to government contracts, CEO and CFO certifications, and financial data formatted in iXBRL - The exhibits filed with this report include various modifications to contracts with BARDA and AstraZeneca, as well as required CEO and CFO certifications[325](index=325&type=chunk)[328](index=328&type=chunk)
Emergent BioSolutions(EBS) - 2021 Q1 - Earnings Call Transcript
2021-04-30 04:23
Emergent BioSolutions, Inc. (NYSE:EBS) Q1 2021 Earnings Conference Call April 29, 2021 5:00 PM ET Company Participants Robert Burrows - VP, IR Robert Kramer - CEO, President & Executive Director Richard Lindahl - EVP, CFO & Treasurer Adam Havey - EVP, Business Operations Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Dana Flanders - Guggenheim Securities Jessica Fye - JPMorgan Chase & Co. Keay Nakae - Chardan Capital Markets Lisa Springer - Singular Research Operator Thank you for sta ...
Emergent BioSolutions(EBS) - 2021 Q1 - Quarterly Report
2021-04-29 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33137 EMERGENT BIOSOLUTIONS INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 14-1902018 (State or Other Jur ...
Emergent BioSolutions(EBS) - 2020 Q4 - Annual Report
2021-02-18 16:00
UNITED STATES 400 Professional Drive, Suite 400 (Address of Principal Executive Offices) Gaithersburg MD 21079 (City) (State) (Zip Code) SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33137 EME ...