Emergent BioSolutions Reports Financial Results for Second Quarter and Six Months Ended June 30, 2020 and Revises Upward Full Year 2020 Guidance
- Establishes key collaborations with industry,
U.S. government, and health care providers to help advance COVID-19 vaccine and therapeutic solutions - Current quarter and year-to-date performance reflect strength of core medical countermeasure business and increased impact of CDMO business
“While we mobilize to meet the threat presented by COVID-19, we are also successfully delivering on our long-term strategy,” said
FINANCIAL HIGHLIGHTS (unaudited)
(in millions) | Q2 2020 | Q2 2019 | $ Change | % Change | |||||
Total Revenues | 62.3% | ||||||||
Net Income (Loss) | * | ||||||||
Adjusted Net Income (1) | * | ||||||||
Adjusted EBITDA (1) | 431.0% |
(in millions) | YTD 2020 | YTD 2019 | $ Change | % Change | |||||
Total Revenues | 35.3% | ||||||||
Net Income (Loss) | 325.3% | ||||||||
Adjusted Net Income (1) | * | ||||||||
Adjusted EBITDA (1) | 355.9% | ||||||||
* % change is greater than 500% |
Q2 2020 AND OTHER RECENT BUSINESS ACCOMPLISHMENTS
- Awarded landmark public-private contract development and manufacturing (CDMO) partnership task order by the
U.S. Department of Health and Human Services (HHS) under Operation Warp Speed valued at approximately$628 million for production of leading pharmaceutical and biotechnology innovators’ COVID-19 vaccine candidates through 2021 and viral drug product capacity expansion at the Company’sRockville, Maryland facility
- Signed five-year large-scale drug substance manufacturing agreement for Johnson & Johnson’s lead COVID-19 vaccine candidate beginning in 2021, valued at approximately
$480 million for the first two years; follows initial agreement, valued at approximately$135 million , to provide CDMO services and secure large-scale manufacturing capacity
- Signed three-year large-scale drug substance manufacturing agreement for AstraZeneca’s COVID-19 vaccine candidate, valued at approximately
$174 million through 2021; follows initial agreement, valued at approximately$87 million , to provide CDMO services and secure large-scale manufacturing capacity
- Awarded
$34.6 million by theU.S. Department of Defense Joint Program Executive Office and formed collaboration withMount Sinai Health System and ImmunoTek Bio Centers to advance the Company’s COVID- Human Immune Globulin (COVID-HIG) therapeutic candidate for potential post-exposure prophylaxis in populations at high risk of COVID-19
- Announced contract option valued at
$258 million exercised by HHS to continue to procure AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) for delivery into theU.S. Strategic National Stockpile (SNS) over 12 months
- Announced contract option valued at
$176 million exercised by HHS to continue to procure ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) for delivery into the SNS over 12 months
- Executed contract option valued at
$54 million exercised by HHS to continue to procure VIGIV [Vaccinia Immune Globulin Intravenous (Human)] for delivery into the SNS over 12 months
- Announced a
$75 million CDMO investment in the Company’sCanton, Massachusetts facility and drug substance expansion into viral vector and gene therapy, expected to be available in Q2 2023
2020 FINANCIAL PERFORMANCE (unaudited)
(I) Quarter Ended
Revenues
Total Revenues
For Q2 2020, total revenues were
Product Sales
For Q2 2020, product sales were
(in millions) |
Three Months Ended |
|||||
2020 | 2019 | % Change | ||||
Product Sales | ||||||
NARCAN Nasal Spray | —% | |||||
ACAM2000 | NM | |||||
Anthrax vaccines | NM | |||||
Other | (69)% | |||||
Total Product Sales | 63% |
For Q2 2020, revenue from the Company’s contract development and manufacturing operations was
Contracts and Grants
For Q2 2020, revenue from the Company’s development-based contracts and grants was
Operating Expenses
Cost of Product Sales and
For Q2 2020, cost of product sales and contract development and manufacturing services was
Research and Development (Gross and Net)
For Q2 2020, gross R&D expenses were
For Q2 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was
(in millions) |
Three Months Ended |
|||||||
2020 | 2019 | % Change | ||||||
Research and Development Expenses | (25)% | |||||||
Adjustments: | ||||||||
Less Contracts and Grants Revenue | (42)% | |||||||
6% | ||||||||
Adjusted Revenue (Total Revenue less Contracts and Grants Revenue) |
84% | |||||||
Net R&D as % of Adjusted Revenue (Net R&D Margin) | 7% | 11% | NA |
Selling, General and Administrative
For Q2 2020, selling, general and administrative expenses were
Amortization of Intangible Assets
For Q2 2020, amortization of intangible assets was
Income Taxes
For Q2 2020, the income tax provision in the amount of
Net Income (Loss) & Adjusted Net Income
For Q2 2020, the Company recorded net income of
For Q2 2020, the Company recorded adjusted net income of
Adjusted EBITDA
For Q2 2020, the Company recorded adjusted EBITDA of
(II) Six months ended
Revenues
Total Revenues
For the six months ended
Product Sales
For the six months ended
(in millions) |
Six Months Ended |
|||||
2020 | 2019 | % Change | ||||
Product Sales | ||||||
NARCAN Nasal Spray | 5% | |||||
ACAM2000 | 35% | |||||
Anthrax vaccines | NM | |||||
Other | (55)% | |||||
Total Product Sales | 33% |
For the six months ended
Contracts and Grants
For the six months ended
Operating Expenses
Cost of Product Sales and
For the six months ended
Research and Development (Gross and Net)
For the six months ended
For the six months ended
(in millions) |
Six Months Ended June 30, | |||||||
2020 | 2019 | % Change | ||||||
Research and Development Expenses | -18% | |||||||
Adjustments: | ||||||||
Less Contracts and Grants Revenue | (26)% | |||||||
(6)% | ||||||||
Adjusted Revenue (Total Revenue less Contracts and Grants Revenue) |
46% | |||||||
Net R&D as % of Adjusted Revenue (Net R&D Margin) | 8% | 13% | NA |
Selling, General and Administrative
For the six months ended
Amortization of Intangible Assets
For the six months ended
Income Taxes
For the six months ended
Net Income (Loss) & Adjusted Net Income
For the six months ended
For the six months ended
Adjusted EBITDA
For the six months ended
2020 FINANCIAL FORECAST
Based upon the Company's financial performance year to date as well as expectations for the remainder of the year, the Company has revised its full year 2020 financial forecast reflected by the following financial metrics and accompanying operational considerations:
Financial Metrics
(in millions) |
REVISED 2020 FORECAST (As of 7/30/2020) |
previous 2020 forecast (As of 4/30/2020) |
Total Revenues | ||
• NARCAN Nasal Spray | ||
• Anthrax vaccines | ||
• ACAM2000 | ||
• Contract development and manufacturing services | ||
Adjusted Net Income (1) | ||
Adjusted EBITDA (1) |
Operational Considerations
- Year over year improvement in gross margin of 400 - 600 basis points (previous range 200 - 400 basis points) driven by improved product mix and increased contribution from our CDMO business;
- The delay into 2021 of the launch of the Phase 3 clinical study for CHIKV-VLP, the Company’s chikungunya virus virus-like particle vaccine, due to the timing of certain operational factors;
- The deferral into 2021 of a follow-on procurement contract with the
U.S. government for raxibacumab, the Company’sFood and Drug Administration -approved anthrax monoclonal antibody therapeutic, due to the impact of the prioritization of Operation Warp Speed on the Company's technology transfer activities for the product; - Continued challenges through the end of 2020 in the Company’s travel health business and revenues associated with Vaxchora®(Cholera Vaccine, Live, Oral) and Vivotif®(Typhoid Vaccine Live Oral Ty21a)
- No generic competition in 2020 for NARCAN®(naloxone HCl) Nasal Spray.
Emergent has assessed the risks to its business associated with the COVID-19 pandemic and has adopted measures to mitigate those risks as they are understood today and accordingly is providing this outlook for 2020. Despite the lack of expected material disruption to the company’s business, the management team continues to assess the business and operational implications associated with the pandemic and market conditions on its employees, patients and customers.
The outlook for 2020 does not include estimates for potential new corporate development or other M&A transactions.
Q3 2020 REVENUE FORECAST
For Q3 2020, the Company forecast for total revenues is
FOOTNOTES
(1) See “Reconciliation of Net Income (Loss) to Adjusted Net Income and Adjusted EBITDA” for a definition of terms and the reconciliation tables.
CONFERENCE CALL, PRESENTATION SUPPLEMENT, AND WEBCAST INFORMATION
Company management will host a conference call at
Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 7380905
Live Webcast Information:
Visit https://edge.media-server.com/mmc/p/bkkqx6kk for the live webcast feed.
A replay of the call can be accessed at www.emergentbiosolutions.com under “Investors.”
ABOUT
visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.
SAFE HARBOR STATEMENT
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, our financial guidance and related projections and statements regarding our ability to meet such projections in the anticipated timeframe, if at all; statements regarding the success of our measures to mitigate the impact on our business and operations of the novel strain of coronavirus (SARS-CoV-2) causing COVID-19 disease; total contract value; annual improvement in gross margin driven by improved product and services mix and sales of certain key components of the product portfolio at specified levels; the lack of generic competition for NARCAN®(naloxone HCl) Nasal Spray for the remainder of 2020; our ability to develop safe and effective treatments for COVID-19 and obtain FDA approval or authorization for emergency or broader patient use of such treatments; the entry into a follow-on procurement contract for raxibacumab in 2021; the launch of the Phase 3 clinical study for CHIKV-VLP; the impact on our revenues from declines in sales of our vaccine products that target travelers due to the reduction of international travel caused by the COVID-19 pandemic and any other statements containing the words “will,” “believes,” “expects,” “anticipates,” “intends,” “plans,” “targets,” “forecasts,” “estimates” and similar expressions in conjunction with, among other things, discussions of the Company’s outlook, financial performance or financial condition, financial and operation goals, strategic goals, growth strategy, product sales, government development or procurement contracts or awards, government appropriations, manufacturing capabilities, and the timing of certain regulatory approvals or expenditures are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate.
Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statements speak only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the impact of global economic conditions and public health crises and epidemics, such as the impact from the global pandemic that arose from the novel strain of coronavirus (SARS-CoV-2) causing COVID-19 disease, on the markets, our operations, and employees as well as those of our customers and suppliers; availability of
Investor Contact | Media Contact |
Vice President, Investor Relations | Senior Director, |
(o) 240/631-3280; (m) 240/413-1917 | (o) 240/631-3392 |
burrowsr@ebsi.com | nerim@ebsi.com |
Consolidated Statements of Operations
(unaudited, in millions, except per share data)
ASSETS |
||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 268.8 | $ | 167.8 | ||
Restricted cash | 0.2 | 0.2 | ||||
Accounts receivable, net | 258.6 | 270.7 | ||||
Inventories | 236.2 | 222.5 | ||||
Prepaid expenses and other current assets | 32.1 | 25.0 | ||||
Total current assets | 795.9 | 686.2 | ||||
Property, plant and equipment, net |
580.1 |
542.3 |
||||
Intangible assets, net | 693.2 | 712.9 | ||||
In-process research and development | 29.0 | 29.0 | ||||
266.3 | 266.6 | |||||
Other assets | 101.6 | 90.3 | ||||
Total assets | $ | 2,466.1 | $ | 2,327.3 |
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable | $ | 84.8 | $ | 94.8 | ||
Accrued expenses | 33.8 | 39.5 | ||||
Accrued compensation | 59.0 | 62.4 | ||||
Debt, current portion | 29.1 | 12.9 | ||||
Contract liabilities, current portion | 32.7 | 3.3 | ||||
Contingent consideration, current portion | 22.3 | 3.2 | ||||
Other current liabilities | 32.0 | 0.2 | ||||
Total current liabilities | 293.7 | 216.3 | ||||
Contingent consideration, net of current portion | 6.9 | 26.0 | ||||
Debt, net of current portion | 758.1 | 798.4 | ||||
Deferred tax liability | 63.9 | 63.9 | ||||
Contract liabilities, net of current portion | 85.3 | 85.6 | ||||
Other liabilities | 59.4 | 48.6 | ||||
Total liabilities | $ | 1,267.3 | $ | 1,238.8 | ||
Stockholders' equity: |
Preferred stock, outstanding |
— | — | ||||
Common stock, |
0.1 | 0.1 | ||||
(39.6 | ) | (39.6 | ) | |||
Additional paid-in capital | 758.5 | 716.1 | ||||
Accumulated other comprehensive loss, net | (22.2 | ) | (9.9 | ) | ||
Retained earnings | 502.0 | 421.8 | ||||
Total stockholders' equity | 1,198.8 | 1,088.5 | ||||
Total liabilities and stockholders' equity | $ | 2,466.1 | $ | 2,327.3 |
Consolidated Statements of Operations
(unaudited, in millions, except per share data)
Three Months Ended |
Six Months Ended |
||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||
Revenues: |
|||||||||||
Product sales, net | $ | 298.5 | 183.5 | 446.7 | 336.5 | ||||||
Contract development and manufacturing | |||||||||||
services | 72.6 | 18.7 | 94.3 | 34.6 | |||||||
Contracts and grants | 23.6 | 41.0 | 46.2 | 62.8 | |||||||
Total revenues | 394.7 | 243.2 | 587.2 | 433.9 | |||||||
Operating expenses: | |||||||||||
Cost of product sales and contract development and manufacturing services | 129.8 |
100.8 |
206.7 |
192.7 |
|||||||
Research and development | 47.9 | 63.9 | 90.6 | 110.0 | |||||||
Selling, general and administrative | 76.0 | 70.8 | 145.7 | 136.4 | |||||||
Amortization of intangible assets | 15.0 | 14.7 | 29.8 | 29.2 | |||||||
Total operating expenses | 268.7 | 250.2 | 472.8 | 468.3 | |||||||
Income (loss) from operations | 126.0 | (7.0 | ) | 114.4 | (34.4 | ) | |||||
Other income (expense): | |||||||||||
Interest expense | (6.4 | ) | (9.5 | ) | (15.0 | ) | (19.0 | ) | |||
Other, net | 1.1 | 1.4 | 0.0 | 0.4 | |||||||
Total other income (expense), net | (5.3 | ) | (8.1 | ) | (15.0 | ) | (18.6 | ) | |||
Income (loss) before provision for income |
|||||||||||
taxes | 120.7 | (15.1 | ) | 99.4 | (53.0 | ) | |||||
Income tax provision (benefit) | 28.0 | (5.6 | ) | 19.2 | (17.4 | ) | |||||
Net income (loss) | $ | 92.7 | (9.5 | ) | 80.2 | (35.6 | ) | ||||
Net income (loss) per common share |
|||||||||||
Basic | $ | 1.76 | (0.18 | ) | 1.53 | (0.69 | ) | ||||
Diluted | $ | 1.73 | (0.18 | ) | 1.51 | (0.69 | ) |
Shares used in computing income (loss) per share | ||||
Basic | 52.6 | 51.5 | 52.3 | 51.3 |
Diluted | 53.5 | 51.5 | 53.2 | 51.3 |
Condensed Consolidated Statements of Cash Flows
(unaudited, in millions)
Six Months Ended |
||||||
Cash flows provided by operating activities: | ||||||
Net income (loss) | $ | 80.2 | $ | (35.6 | ) | |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||||||
Stock-based compensation expense | 31.0 | 14.9 | ||||
Depreciation and amortization | 56.8 | 55.1 | ||||
Amortization of deferred financing costs | 1.5 | 1.5 | ||||
Deferred income taxes | (3.7 | ) | (1.3 | ) | ||
Change in fair value of contingent consideration, net | 1.1 | 5.5 | ||||
Other | 1.1 | 2.9 | ||||
Changes in operating assets and liabilities: | ||||||
Accounts receivable | 12.1 | 44.6 | ||||
Inventories | (13.7 | ) | (26.1 | ) | ||
Prepaid expenses and other assets | (16.9 | ) | (44.9 | ) | ||
Accounts payable | (14.5 | ) | 42.6 | |||
Accrued expenses | 25.0 | 6.9 | ||||
Accrued compensation | (3.4 | ) | (13.5 | ) | ||
Contract liabilities | 29.1 | 16.4 | ||||
Net cash provided by operating activities: | 185.7 | 69.0 | ||||
Cash flows used in investing activities: |
||||||
Purchases of property, plant and equipment and other | (59.3 | ) | (35.5 | ) | ||
Milestone payment from prior asset acquisition | (10.0 | ) | (10.0 | ) | ||
Net cash used in investing activities: | (69.3 | ) | (45.5 | ) | ||
Cash flows (used in) provided by financing activities: |
||||||
Proceeds from revolving credit facility | — | 130.0 | ||||
Principal payments on revolving credit facility | (20.0 | ) | (80.0 | ) | ||
Principal payments on term loan facility | (5.6 | ) | (5.6 | ) | ||
Proceeds from exercise of stock options | 23.1 | 4.6 | ||||
Taxes paid for share-based compensation activity | (11.7 | ) | (6.3 | ) | ||
Contingent consideration payments | (1.1 | ) | (1.0 | ) | ||
Net cash (used in) provided by financing activities: | (15.3 | ) | 41.7 | |||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (0.1 | ) | — | |||
Net increase in cash, cash equivalents and restricted cash | 101.0 | 65.2 | ||||
Cash, cash equivalents and restricted cash at beginning of period | 168.0 | 112.4 | ||||
Cash, cash equivalents and restricted cash at end of period | $ | 269.0 | $ | 177.6 |
RECONCILIATION OF NET INCOME (LOSS) TO ADJUSTED NET INCOME AND ADJUSTED EBITDA (unaudited)
This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Depreciation and Amortization, Interest and Taxes)) that are considered “non-GAAP” financial measures under applicable
The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety.
Reconciliation of Net Income (Loss) to Adjusted Net Income (Unaudited)
(in millions, except per share value) |
Three Months Ended |
||||||
2020 | 2019 | Source | |||||
Net income (loss) | ( |
||||||
Adjustments: | |||||||
+ Acquisition-related costs (transaction & integration) | — | 3.5 | SG&A | ||||
+ Non-cash amortization charges | 15.8 | 15.4 | SG&A, Other Income | ||||
+ Changes in fair value of contingent consideration | 0.5 | 3.9 | SG&A | ||||
+ Impact of purchase accounting on inventory step-up | — | 1.1 | COGS | ||||
Tax effect | (3.3) | (4.2) | |||||
Total adjustments: | 13.0 | 19.7 | |||||
Adjusted net income | $ 105.7 | $ 10.2 | |||||
Adjusted net income per diluted share |
(in millions, except per share value) |
Six Months Ended |
||||||
2020 | 2019 | Source | |||||
Net income (loss) | ( |
||||||
Adjustments: | |||||||
+ Acquisition-related costs (transaction & integration) | — | 7.4 | SG&A | ||||
+ Non-cash amortization charges | 31.3 | 30.7 | SG&A, Other Income | ||||
+ Changes in fair value of contingent consideration | 1.1 | 5.5 | COGS | ||||
+ Impact of purchase accounting on inventory step-up | — | 6.1 | COGS | ||||
Tax effect | (6.6) | (9.3) | |||||
Total adjustments: | 25.8 | 40.4 | |||||
Adjusted net income | |||||||
Adjusted net income per diluted share |
(in millions) |
REVISED 2020 Full Year Forecast | ||
2020F | Source | ||
Net income | |||
Adjustments: | |||
+ Non-cash amortization charges | 62 | Intangible Asset Amortization, Other Income | |
+ Change in fair value of contingent consideration | 2 | COGS | |
Tax effect | (14) | ||
Total adjustments: | 50 | ||
Adjusted net income |
Reconciliation of Net Income (Loss) to Adjusted EBITDA (Unaudited)
(in millions) |
Three Months Ended |
|||
2020 | 2019 | |||
Net income (loss) | ( |
|||
Adjustments: | ||||
+ Depreciation & amortization | 28.6 | 27.2 | ||
+ Provision (benefit) for (from) income taxes | 28.0 | (5.6) | ||
+ Total interest expense, net* | 6.3 | 8.8 | ||
+ Changes in fair value of contingent consideration | 0.5 | 3.9 | ||
+ Acquisition-related costs (transaction & integration) | — | 3.5 | ||
+ Impact of purchase accounting on inventory step-up | — | 1.1 | ||
Total adjustments | 63.4 | 38.9 | ||
Adjusted EBITDA | ||||
* Includes interest income of |
(in millions) |
Six Months Ended |
|
2020 | 2019 | |
Net income (loss) | ( |
|
Adjustments: | ||
+ Depreciation & amortization | 56.8 | 53.8 |
+ Provision (benefit) for (from) income taxes | 19.2 | (17.4) |
+ Total interest expense, net* | 14.1 | 17.8 |
+ Changes in fair value of contingent consideration | 1.1 | 5.5 |
+ Acquisition-related costs (transaction & integration) | — | 7.4 |
+ Impact of purchase accounting on inventory step-up | — | 6.1 |
Total additional adjustments | 91.2 | 73.2 |
Adjusted EBITDA | ||
* Includes interest income of |
(in millions) |
REVISED 2020 Full Year Forecast |
2020F | |
Net income | |
Adjustments: | |
+ Depreciation & amortization | 115 |
+ Provision for income taxes | 98 to 113 |
+ Total interest expense | 30 |
+ Change in fair value of contingent consideration | 2 |
Total additional adjustments | 245 to 260 |
Adjusted EBITDA |
Source: Emergent BioSolutions